HSA | Template forms

<!DOCTYPE html> <html class="no-js" lang="en"> <head> <meta charset="utf-8"> <meta content="ie=edge" http-equiv="x-ua-compatible"> <meta name="viewport" content="width=device-width, initial-scale=1, shrink-to-fit=no"> <link rel="stylesheet" href="https://fonts.googleapis.com/css?family=Source+Sans+Pro:400,600,700" /> <link rel="stylesheet" href="/_assets/stylesheets/style.min.css" /> <link rel="stylesheet" href="/_assets/stylesheets/carapace.min.css" /> <link rel="apple-touch-icon" sizes="180x180" href="/_assets/images/favicons/apple-touch-icon.png"> <link rel="icon" type="image/png" sizes="32x32" href="/_assets/images/favicons/favicon-32x32.png"> <link rel="icon" type="image/png" sizes="16x16" href="/_assets/images/favicons/favicon-16x16.png"> <link rel="mask-icon" href="/_assets/images/favicons/safari-pinned-tab.svg" color="#7d7d7d"> <meta name="theme-color" content="#ffffff"> <script src="/ScriptResource.axd?d=ktXPS54N4JY6vbaCTPlT9TQp2wMU3hn-M_pNBj3sR9RSvPDpPCZb4RCX4MB1ykeieWbLW86nwHBEIsRGv4PQ21cQwr1euHDvOObVJuqZ4WEep_uIszmqL1Is1RESNzVt0t3-Xz_SrDO2gnMiEc0Yko_CMLG0t6doJCQlG9rW8ofuvtKS_QZ1UUMRAOQbzvew0&t=ffffffffd6a0888d" type="text/javascript"></script><script src="/ScriptResource.axd?d=ePnjFy9PuY6CB3GWMX-b_0Kwu6S_aT--bf0l3hwaEeLN9EKrdG8KH40INZVxTiu0CDkcsCFjMSmDNDnxxaDXs81FcWoV0HITK5ohA6fYQmpUNXGRkMLycrkM-QFkr4XK1Ucq3fPiIQEMjToOfU32TWTTb8PzA46H5C4Xoz47oHS7OjsAyyga3jezWTdj___E0&t=ffffffffd6a0888d" type="text/javascript"></script> <meta property="og:title" content="HSA | Template forms" /><meta property="og:description" content="Refer to this list of template forms to assist you in conducting clinical trials.&nbsp;" /><meta property="og:url" content="https://www.hsa.gov.sg/clinical-trials/conducting/template-forms" /><meta property="og:type" content="website" /><meta property="og:site_name" content="HSA" /><style type="text/css" media="all">html, body { -webkit-text-size-adjust: 100% !important; }</style><script type="text/javascript" src="https://assets.wogaa.sg/scripts/wogaa.js"></script><style type="text/css" media="all">#hsa-base .hsa-glyphs--social-twitter-account:before { content: url("data:image/svg+xml,%3Csvg xmlns='http://www.w3.org/2000/svg' width='1em' height='1em' viewBox='0 0 16 16'%3E%3Cpath fill='%23ffffff33' d='M9.294 6.928L14.357 1h-1.2L8.762 6.147L5.25 1H1.2l5.31 7.784L1.2 15h1.2l4.642-5.436L10.751 15h4.05zM7.651 8.852l-.538-.775L2.832 1.91h1.843l3.454 4.977l.538.775l4.491 6.47h-1.843z'/%3E%3C/svg%3E"); }</style><link rel="canonical" href="https://www.hsa.gov.sg/clinical-trials/conducting/template-forms" /><link href="/Telerik.Web.UI.WebResource.axd?d=PMrIT5dOWaVYIcpFWUE4nEXqcmghtrcdB8OyXwrdyyaVmd3DkmqtYE6sU4x3tKGv2e5adHsgsTMyPvggIMP-fYO7DgjeesTbghMDDLmAQEyd3bHioWZtg0SsA2xXBLJJ0&t=638628495619626917&compress=0&_TSM_CombinedScripts_=%3b%3bTelerik.Sitefinity.Resources%2c+Version%3d14.4.8140.0%2c+Culture%3dneutral%2c+PublicKeyToken%3db28c218413bdf563%3aen%3a4f102d98-8cc9-4b2a-bf0d-b66909440278%3a7a90d6a" type="text/css" rel="stylesheet" /><title> HSA | Template forms </title><meta name="description" content="Refer to this list of template forms to assist you in conducting clinical trials.&nbsp;" /><meta name="keywords" content="template forms" /></head> <body id="hsa-base" class="hsa-print-container"><form method="post" action="./template-forms" id="aspnetForm"> <input type="hidden" name="ctl04_TSM" id="ctl04_TSM" value="" /> <input type="hidden" name="ctl05_TSSM" id="ctl05_TSSM" value="" /> <input type="hidden" name="__VIEWSTATE" id="__VIEWSTATE" value="3YAIzTmTuWE62pikCwavjKrle9//HdGoPSuwgD26zg52t4Bu/WooUwvdtMoZ2zw7mYfvbjHoBNVGRD2w1StptP0WTiQj7HCOPUX4irQX4mE=" /> <script type="text/javascript"> //<![CDATA[ var __cultureInfo = {"name":"en","numberFormat":{"CurrencyDecimalDigits":2,"CurrencyDecimalSeparator":".","IsReadOnly":true,"CurrencyGroupSizes":[3],"NumberGroupSizes":[3],"PercentGroupSizes":[3],"CurrencyGroupSeparator":",","CurrencySymbol":"$","NaNSymbol":"NaN","CurrencyNegativePattern":0,"NumberNegativePattern":1,"PercentPositivePattern":1,"PercentNegativePattern":1,"NegativeInfinitySymbol":"-∞","NegativeSign":"-","NumberDecimalDigits":2,"NumberDecimalSeparator":".","NumberGroupSeparator":",","CurrencyPositivePattern":0,"PositiveInfinitySymbol":"∞","PositiveSign":"+","PercentDecimalDigits":2,"PercentDecimalSeparator":".","PercentGroupSeparator":",","PercentSymbol":"%","PerMilleSymbol":"‰","NativeDigits":["0","1","2","3","4","5","6","7","8","9"],"DigitSubstitution":1},"dateTimeFormat":{"AMDesignator":"AM","Calendar":{"MinSupportedDateTime":"\/Date(-62135596800000)\/","MaxSupportedDateTime":"\/Date(253402271999999)\/","AlgorithmType":1,"CalendarType":1,"Eras":[1],"TwoDigitYearMax":2049,"IsReadOnly":true},"DateSeparator":"/","FirstDayOfWeek":0,"CalendarWeekRule":0,"FullDateTimePattern":"dddd, MMMM d, yyyy h:mm:ss tt","LongDatePattern":"dddd, MMMM d, yyyy","LongTimePattern":"h:mm:ss tt","MonthDayPattern":"MMMM d","PMDesignator":"PM","RFC1123Pattern":"ddd, dd MMM yyyy HH\u0027:\u0027mm\u0027:\u0027ss \u0027GMT\u0027","ShortDatePattern":"M/d/yyyy","ShortTimePattern":"h:mm tt","SortableDateTimePattern":"yyyy\u0027-\u0027MM\u0027-\u0027dd\u0027T\u0027HH\u0027:\u0027mm\u0027:\u0027ss","TimeSeparator":":","UniversalSortableDateTimePattern":"yyyy\u0027-\u0027MM\u0027-\u0027dd HH\u0027:\u0027mm\u0027:\u0027ss\u0027Z\u0027","YearMonthPattern":"MMMM yyyy","AbbreviatedDayNames":["Sun","Mon","Tue","Wed","Thu","Fri","Sat"],"ShortestDayNames":["Su","Mo","Tu","We","Th","Fr","Sa"],"DayNames":["Sunday","Monday","Tuesday","Wednesday","Thursday","Friday","Saturday"],"AbbreviatedMonthNames":["Jan","Feb","Mar","Apr","May","Jun","Jul","Aug","Sep","Oct","Nov","Dec",""],"MonthNames":["January","February","March","April","May","June","July","August","September","October","November","December",""],"IsReadOnly":true,"NativeCalendarName":"Gregorian Calendar","AbbreviatedMonthGenitiveNames":["Jan","Feb","Mar","Apr","May","Jun","Jul","Aug","Sep","Oct","Nov","Dec",""],"MonthGenitiveNames":["January","February","March","April","May","June","July","August","September","October","November","December",""]},"eras":[1,"A.D.",null,0]};//]]> </script> <script src="/Telerik.Web.UI.WebResource.axd?_TSM_HiddenField_=ctl04_TSM&compress=0&_TSM_CombinedScripts_=%3b%3bSystem.Web.Extensions%2c+Version%3d4.0.0.0%2c+Culture%3dneutral%2c+PublicKeyToken%3d31bf3856ad364e35%3aen%3a95047a2c-8908-49e3-b68e-d249be89f134%3aea597d4b" type="text/javascript"></script> <input type="hidden" name="__VIEWSTATEGENERATOR" id="__VIEWSTATEGENERATOR" value="B865E4CF" /><input type="hidden" name="ctl00$ctl04" id="ctl04" /> <script type="text/javascript"> //<![CDATA[ Sys.Application.setServerId("ctl04", "ctl00$ctl04"); Sys.Application._enableHistoryInScriptManager(); //]]> </script>  <noscript> <iframe src="https://www.googletagmanager.com/ns.html?id=GTM-TVHGN2W" height="0" width="0" style="display:none;visibility:hidden" sandbox></iframe> </noscript>  <div > <div ><a class="hsa-skiplink" href="#content">Skip to main content</a> <div class="hsa-masthead"><a href="https://www.gov.sg/" target="_blank" rel="noopener"><img class="hsa-masthead__logo" src="/_assets/images/logo-mark-singapore-government.svg" alt="Singapore Government" /><span>A Singapore Government Agency Website</span></a></div></div> </div> <header class="hsa-header" role="banner"> <div class="hsa-header__container g:12"> <div class="gcol:12 ta:c dsk(ta:l) d:f jc:c tab(jc:fs) ai:c"> <a class="type--inherit" href="/"> <img alt="Health Sciences Authority" class="hsa-img--hsa-logo" src="/_assets/images/logo-hsa.svg"> </a> <div class="d:n dsk(d:b) m-l:l"> <a href="#" class="hsa-header__nav-link hsa-header__nav-toggle-menu"><span class="hsa-hamburgers m-r:xs"><span class="hsa-hamburgers__lines"></span> </span><span>Products regulation</span> </a> <a class="hsa-header__nav-link" href="/blood-donation">Blood donation</a> <a class="hsa-header__nav-link" href="/lab-services">Lab services</a> <a class="hsa-header__nav-link" href="/about-us">Who we are</a> <a class="hsa-header__nav-link" href="/e-services">E-services</a> </div> <button type="button" class="hsa-font-decrease d:n ldsk(d:if)"><span class="hsa-glyphs--Aminus"></span> <span class="fz:0">Decrease font size</span></button> <button type="button" class="hsa-font-increase d:n ldsk(d:if)"><span class="hsa-glyphs--Aplus"></span> <span class="fz:0">Increase font size</span></button> <button type="button" class="hsa-nav__search-btn d:n ldsk(d:f)"><span class="hsa-glyphs--search"></span> <span class="hsa-nav__search-btn__text">Search</span></button> </div> </div> <div class="hsa-header__search"> <div class="hsa-header__search-panel container"> <button type="button" class="hsa-header__search-panel__close"> <span class="hsa-glyphs--chevron-up"></span> hide </button> <div class="g:12"> <div class="gcol:12"> <div id="hsa-header__search-panel__input"></div> </div> </div> </div> </div> <aside aria-label="menu" id="navigation-sidebar" class="hsa-header__sidebar"> <div class="hsa-header__sidebar__controller"> <button class="hsa-header__sidebar__menu-btn active" type="button" aria-controls="navigation-sidebar"><span class="hsa-hamburgers m-r:xs"><span class="hsa-hamburgers__lines"></span> </span><span class="hsa-header__sidebar__menu-btn__text">Close</span></button> <ul class="hsa-header__sidebar__controller__scrollbar"> <li class="link d:b dsk(d:n) divider"> <a class="state--ignore-tooltip" href="/e-services"><span class="hsa-glyphs--cog"></span> E-services</a> </li> <li class="hsa-header__sidebar__controller__group product-regulations"> <span class="hsa-header__sidebar__controller__group__header">Product Regulations</span> <ul> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="2fa7c40c-9b3d-4679-b2ab-79d113f9f0e8">Medical devices</a> </li> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="02a741e1-7ebb-4de5-aa7a-bfeafb1a2f0f">Therapeutic products</a> </li> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="246268ec-0756-45b3-bb95-b3c4a6da2846">Health supplements</a> </li> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="9895f1ad-a865-4b50-89e5-98b27e3af020">Traditional medicines</a> </li> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="7680548f-411c-4b43-8fe7-4da5f27833c8">Chinese proprietary medicines</a> </li> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="6fb37491-3203-4b13-a276-7bbef8b824a9">Cosmetic products</a> </li> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="4617683f-c959-4829-b97a-b3cdb93ccb68">Tobacco regulation</a> </li> <li class="parent" data-content="product-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="979de975-13ac-4941-8c9c-1527e7dde9d3">CTGTP</a> </li> </ul> </li> <li class="hsa-header__sidebar__controller__group more-regulations"> <span class="hsa-header__sidebar__controller__group__header">More Regulations</span> <ul> <li class="parent" data-content="more-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="0b00adf2-a40d-4ea3-bc12-b0aaf14c0ab5">Active ingredients</a> </li> <li class="parent" data-content="more-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="3864b786-c4b7-4761-93f5-8f0738454fc0">Clinical trials</a> </li> <li class="parent" data-content="more-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="bddf8db1-ce0e-497d-ae77-857efec4566e">Controlled drugs and psychotropic substances</a> </li> <li class="link" data-content="more-regulations"> <a class="state--ignore-tooltip" href="/homeopathic-medicines">Homoeopathic medicines </a> </li> <li class="link" data-content="more-regulations"> <a class="state--ignore-tooltip" href="/medicated-oils-and-balms">Medicated oils, balms and medicated plasters</a> </li> <li class="parent" data-content="more-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="e5c77d76-09c8-40ba-ae32-8960fd5212a7">Poisons</a> </li> <li class="parent" data-content="more-regulations"> <a class="state--ignore-tooltip" href="#" data-guid="de6b77c3-03f4-4b75-8f1a-fe28c36f7fd0">Topical antiseptics</a> </li> </ul> </li> <li class="link"> <a class="state--ignore-tooltip" href="/rmp" >Risk management plan requirements</a> </li> <li class="link"> <a class="state--ignore-tooltip" href="/adverse-events" >Report adverse events</a> </li> <li class="link"> <a class="state--ignore-tooltip" href="/international-collaboration" >International collaboration</a> </li> <li class="link d:b dsk(d:n)"> <a class="state--ignore-tooltip" href="/blood-donation">Blood donation</a> </li> <li class="link d:b dsk(d:n)"> <a class="state--ignore-tooltip" href="/lab-services">Lab services</a> </li> <li class="link d:b dsk(d:n)"> <a class="state--ignore-tooltip" href="/about-us">Who we are</a> </li> </ul> </div> <div class="hsa-header__sidebar__extender"> <div class="hsa-header__sidebar__extender__column-1"> <div data-label="2fa7c40c-9b3d-4679-b2ab-79d113f9f0e8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Medical devices</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/regulatory-overview" data-guid="b24e2731-43c1-4cc4-ae92-b4e0b32848f6"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="7ede8f61-ff1c-4c69-a6a4-df1fd414c539"> Register your device </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/change-notification" data-guid="fbe0159e-5824-4ac5-8823-02cf9b80a768"> Changes to registered devices </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="30939644-bd18-43b4-b6d1-de9a663ccdb4"> Dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/certificates" data-guid="5696f1b9-bfb0-4c99-ab60-799be24a96ac"> Free Sale Certificate and Export Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/adverse-events" data-guid="e902d3d9-c6a2-46b8-adb3-15b4496de04d"> Report adverse events </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="668d06f0-a4bb-4de1-8caf-df59aed1ed04"> Field Safety Corrective Action reporting </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/clinical-trials" data-guid="e074cca9-2d2b-48c4-985d-83833e4b4f72"> Clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/consultation-schemes" data-guid="e0728bc1-d7f2-4760-b501-7fb8a0104633"> Consultation schemes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/advertisements-promotions" data-guid="c575786f-fe89-4ecf-836d-06037d6d227f"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/personal-import" data-guid="78b688d0-a782-4285-bedf-c9644c618ac3"> Bringing personal medical devices into Singapore </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/covid-19-standards-resources-for-essential-medical-devices" data-guid="d68b9ba1-c40b-49de-80c9-248689c8ee1c"> COVID-19: Standards Resources for Essential Medical Devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/digital-health" data-guid="faa4c7e8-8fa5-4907-bba0-cf7323541845"> Digital Health </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="27da00ef-00ec-4790-9d18-6916d678ecfd"> International collaboration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/standards-for-medical-devices" data-guid="e78eb821-29c2-4555-a644-bd437bffb1f8"> Standards for Medical Devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/guidance-documents" data-guid="de28c215-08d1-44a5-af83-ef489b2105fe"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/fees" data-guid="557d7609-331a-47bd-95e5-d4e9fe4cbdac"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="02a741e1-7ebb-4de5-aa7a-bfeafb1a2f0f" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Therapeutic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/overview" data-guid="2cd88bdd-846b-4d7d-ba3f-58efc47f49d6"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="1bb793b7-6ebc-4614-ab26-f3486e8d47b8"> Register your product </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="382c3665-f125-4dbd-aa45-33855a4edecc"> Apply for post-approval variation </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="c7d36f32-24f2-4341-852f-879820bd2f95"> Reclassify your product </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="610292f3-004d-4e6e-8995-c25be4a1273b"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retain-cancel-or-transfer-therapeutic-product-registrations" data-guid="51a7ad22-338f-49ae-9336-c385884fdd1f"> Retain, cancel or transfer product registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/rmp" data-guid="73570827-4fc4-4805-b778-0c6ed71d542c"> Risk management plan requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/adverse-events" data-guid="dfc7cd0c-0dd2-4789-bc57-430dce08bca8"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/defect-reporting-recall" data-guid="1e2b6d48-7d73-43f6-ae20-d64c8dcd364b"> Report or recall defective products </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="25fc1ebe-32a2-4170-ae07-309d697d35e5"> Retail pharmacy licensing </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="efa56797-fabe-4d38-810f-4cd825fa6486"> Clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/product-consultation" data-guid="35dd4be5-4f72-4acb-9b50-bb5d5fb283e4"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/advertisements" data-guid="8ff3017a-0e57-49a4-8db1-dfa95bf2a0c8"> Advertisements and promotions </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="c28d32cb-4d78-48ec-bb2a-e42249225222"> CPP and SLS </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="669e5508-668c-45fb-b768-d34e6d5fef95"> International collaboration </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="9abfc5d0-f746-49d7-8c7e-f71d93c182a9"> Medicines quality and compliance monitoring </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/approvals-and-post-reg-actions" data-guid="ef526abe-209f-4f29-bb86-785b2df26818"> Listing of approvals and post-registration actions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/guidance-documents" data-guid="62872c1e-38a5-42f9-a2c8-a8a83702109b"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/fees" data-guid="1579b0f9-3040-487c-b455-9d1225222d98"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="246268ec-0756-45b3-bb95-b3c4a6da2846" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Health supplements</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/overview" data-guid="84b7033f-f384-49c1-9fad-6fce15c92285"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/vns" data-guid="7ec10a91-7ddf-4814-8b8f-1a0e8b12767f"> Voluntary Notification of HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/list-of-notified-health-supplements-and-traditional-medicines" data-guid="3cd877f0-bcc4-43b5-9908-9a514e8c844e"> List of Notified HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/claims" data-guid="a689b476-c59b-42ee-8be8-5935bafc7a00"> Health supplement claims </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/advertisements-and-promotions-of-medicinal-products" data-guid="7b38c6d6-debf-4912-a85b-7effbd0542d1"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/adverse-events-reporting-of-health-supplements" data-guid="d1d02256-9c76-4627-8061-7f0f2e96945c"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/international-collaboration-for-complementary-health-products" data-guid="44cb8d61-8291-4751-8aa5-4a5e4140e007"> International collaboration </a> </li> </ul> </div> <div data-label="9895f1ad-a865-4b50-89e5-98b27e3af020" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Traditional medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/overview" data-guid="0271bb00-51f7-429b-9c70-6b0184385233"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/vns" data-guid="478b3953-40f7-43d2-84f0-f90f43d7b780"> Voluntary Notification of HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/list-of-notified-health-supplements-and-traditional-medicines" data-guid="de01dba9-e076-4233-81ed-3f3cb07476c4"> List of Notified HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/advertisements-and-promotions-of-medicinal-products" data-guid="6ab913a0-34c6-4c0e-98c4-575dfc1f56cf"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/report-adverse-events" data-guid="8f86ce68-926e-491f-ad7b-b1867f32353e"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/traditional-medicinal-materials" data-guid="d18617f7-d012-49c3-93b0-f297a10a4c78"> Traditional medicinal materials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/international-collaboration" data-guid="24d76262-844a-413d-a536-e3129d9e5122"> International collaboration </a> </li> </ul> </div> <div data-label="7680548f-411c-4b43-8fe7-4da5f27833c8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Chinese proprietary medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/overview" data-guid="cd89cf57-15f3-4d97-b828-84e95aff4990"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="dae1b05b-8161-4833-95a5-14b6eda06caf"> Product listing </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="17eb371c-7d1b-4ff8-8586-9190c021a006"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/export" data-guid="2bbcbc75-0270-469e-a292-a0036fc4d414"> Free Sale Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/advertisements-medicinal-products-tmm" data-guid="0a97d25a-e690-4971-92f6-32e0da1303cc"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/adverse-events" data-guid="96939874-b945-4831-92e2-d2134f573983"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/traditional-medicinal-materials" data-guid="257986ec-60d1-48bc-a72a-36362f874a4b"> Traditional medicinal materials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/international-collaboration-for-complementary-health-products" data-guid="f17d68c4-d044-43c9-915a-486f8f6c7c32"> International collaboration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/fees" data-guid="334e5c37-3e3f-400d-acfe-f7dbdf9df385"> Fees and Turnaround time of Chinese Proprietary Medicines </a> </li> </ul> </div> <div data-label="6fb37491-3203-4b13-a276-7bbef8b824a9" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Cosmetic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/overview" data-guid="bd161848-e281-4eb4-88eb-d50718fab34f"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="b6ca1f1f-75c5-4537-be36-0505ef1d1b42"> Cosmetic product notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/asean-cosmetic-directive" data-guid="75199b88-06c7-4911-ade6-c0fae6b5beb1"> ASEAN Cosmetic Directive </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/good-manufacturing-practice" data-guid="41295286-4d99-4719-90a6-80e36db75b62"> Good Manufacturing Practice certification for cosmetic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/report-adverse-events-of-cosmetic-products" data-guid="08ab8f6c-5867-4cde-8a64-29c2b44ee781"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/fees" data-guid="fe44fb88-0d08-4e8c-84cd-7dd749b82b1b"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="4617683f-c959-4829-b97a-b3cdb93ccb68" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco regulation</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/overview" data-guid="e9dbbf4f-2d76-4024-a8e8-31f55492d7b4"> Overview of tobacco control </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="25429b7c-80af-4fa8-bf40-70f62681eb5f"> Tobacco licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/suspended-revoked-licences" data-guid="dac2e9d7-81e1-4a0b-8322-bb68908885de"> List of suspended and revoked licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/report" data-guid="81d704aa-5059-46a4-97ac-1e2ed7577345"> Report tobacco-related offences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/fees" data-guid="cfd6e504-5352-4c4f-a428-21530c94e642"> Fees and turnaround time </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/tobacco-retailer-educational-video-and-quiz" data-guid="a910f388-93e3-4ba7-962b-3fee461fbc95"> Tobacco retailer educational video and quiz </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/vaping-enforcement" data-guid="6ac998c5-a57a-4820-b755-97d5a1a12702"> Vaping enforcement </a> </li> </ul> </div> <div data-label="979de975-13ac-4941-8c9c-1527e7dde9d3" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CTGTP</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/regulatory-overview" data-guid="37e4cfd4-8234-40a4-9c7d-e81b349126b3"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/class1-notification" data-guid="b3c9c340-ad73-4183-a44a-d649ab1b5785"> Class 1 CTGTP notification </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="8bf23c04-8c49-4780-b303-542f375a2b39"> Register a Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/variation" data-guid="9a0f3708-b4df-4965-a393-603cb816fbe3"> Variation applications </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-notice" data-guid="584b3b0a-e144-49e2-975b-079e228e6c8d"> Dealer's notice </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f1513b1d-d5e5-4eb6-aa96-ff39b5c36981"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/rmp" data-guid="751614d8-2439-42e2-af1e-cf1c4317b485"> Risk management plan requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/adverse-events" data-guid="be485ef9-c825-45dc-83d6-ba0d7b0824f8"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/defect-and-recalls" data-guid="49abb8dc-d30b-4a8b-9413-5cb6abd35447"> Report or recall defective products </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="0baf57d7-e63c-4c85-b702-a326bda7a2c4"> Clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/product-consultation" data-guid="f583337c-a42b-4305-a0a1-0a4a925ecfcb"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/advertisements" data-guid="d191cdf2-3199-4595-938d-cc13590e89c0"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/cpp" data-guid="adaa0f41-df0b-4b7f-9eb2-6f7fc35c513e"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/duties-and-obligations" data-guid="bc235ae3-678e-4ae8-a40b-74d2e9bb8fc7"> Duties And Obligations </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/guidance-documents" data-guid="c6ee0f87-ea10-46ce-b7e4-c624336c1a70"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/fees-and-TAT" data-guid="b62d4bbb-97e6-403a-bd29-9ab4b83a94b1"> Fees and turnaround time </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/notified-ctgtp" data-guid="92827969-ea7a-4e98-8c47-7ebe73ff323f"> Notified Class 1 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/ctgtp-register" data-guid="0146ad7a-a482-4a40-9e06-ac39f3ab4e62"> Register of Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/register-of-cell-tissue-or-gene-therapy-products-licensees" data-guid="face7927-ccdd-4a6a-85a0-212dba24d693"> Register of Licensed CTGTP Importers, Wholesalers and Manufacturers </a> </li> </ul> </div> <div data-label="09c13846-b094-41b6-94ef-724cbfda293a" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Bringing personal medications into Singapore</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/overview" data-guid="ef3465c3-1f30-4ff7-8cf0-1783ac3266b0"> Regulations for bringing in personal medications </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/check-requirements" data-guid="5ae34c46-f9c8-475f-871d-fcd85e3e8460"> Check medication requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/submit-application-for-approval-to-bring-in-personal-medications-(new)" data-guid="65a1f011-4fc7-4b84-8e1f-7863289bf53b"> Submit application for approval to bring in personal medication </a> </li> </ul> </div> <div data-label="0b00adf2-a40d-4ea3-bc12-b0aaf14c0ab5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Active ingredients</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/regulatory-overview" data-guid="dcb8d11f-bba3-4ff4-bfb3-981179948c72"> Regulatory Overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f9b17351-9e31-4cbe-9368-89990285d3ab"> Licensing and certification of importers and wholesalers </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="3115698c-9584-4b2a-980e-61f2f1ddce20"> Licensing and certification of manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/certificate-of-a-pharmaceutical-product" data-guid="f04be9be-c430-420a-ac52-f0305b04671c"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/requirements-for-active-ingredients-notification" data-guid="a48c2a91-e94f-461e-b488-154280aa1155"> Active ingredients used in Clinical Research/Clinical Trial </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/guidance-documents" data-guid="9822345f-a5dc-463f-ad36-02059ab63caa"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/fees-and-turnaround-time" data-guid="98f5142a-bfed-475e-9e1e-eeacae915249"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="3864b786-c4b7-4761-93f5-8f0738454fc0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/overview" data-guid="e06cd0df-ef61-43ec-9d14-4d516cfbc560"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="8c5c2c4d-0e40-4323-a87e-b4a3f03a4c2b"> CTA, CTN or CTC submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/crm-notification" data-guid="4cd0dc10-3e32-4dd6-8566-eebb43a02b40"> Submit a CRM notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/good-clinical-practice" data-guid="6eda14e6-f44e-4eb5-9a9f-7946ec0df452"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/adverse-events" data-guid="9d1d8955-7769-4a88-ae31-f21375fc837d"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/innovation-office" data-guid="a970778f-fe31-451c-8bb4-11be032be3d1"> Innovation Office </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="525bb14a-8f6c-4ea3-920d-8126125f5443"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/participating" data-guid="d8ddf9e6-4343-49ed-8bb7-322d59f9df25"> Participating in clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/regulatory-guidances" data-guid="43b28bbc-936f-4bab-8b59-cab37069b687"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/clinical-trials-register" data-guid="b5fb8906-c682-4bda-839a-9043ec9e3a72"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/statistics" data-guid="47ae6c12-8e21-4b6c-9632-2a9ec584dea7"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="bddf8db1-ce0e-497d-ae77-857efec4566e" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Controlled drugs and psychotropic substances</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="2dfb1261-9d74-487f-b59a-8f0c75330def"> Controlled drugs </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/psychotropic-substances" data-guid="9368ffd0-861d-42af-a664-3128948d061c"> Psychotropic substances </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/restricted-substances" data-guid="3b4abff4-06ed-4895-8031-b263d2d1f16a"> Restricted substances </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/fees" data-guid="8f70fe0f-d8f7-4565-9dcc-acec2ff00efd"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="e5c77d76-09c8-40ba-ae32-8960fd5212a7" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Poisons</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/overview" data-guid="0a0b16ae-b87a-464e-afbc-6318a4d0078e"> Overview of Form A Poisons Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/apply" data-guid="eb91b4aa-a3f3-4535-a294-1006eb31b074"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/amend" data-guid="0e4a341a-ee1c-4dfa-9079-0d8fb2835567"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/renew" data-guid="bc36d7bb-a0fe-4558-969f-a56a849c1d30"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/fees" data-guid="fe3dc090-03e8-4b05-88ee-47aa717da9b9"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="de6b77c3-03f4-4b75-8f1a-fe28c36f7fd0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Topical antiseptics</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/topical-antiseptics/overview" data-guid="b0bda773-e4cd-43d6-801c-5910a6addc0d"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/topical-antiseptics/classification" data-guid="c957249f-9b1c-4e2a-b196-d791b90fc6a0"> Topical antiseptics classification guide </a> </li> </ul> </div> <div data-label="1b050871-6f13-424b-9169-c5f607c45b70" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">COVID-19 regulatory information and consumer advisories</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/covid-19-information-and-advisories/hsa_review_swiss_study" data-guid="fb1a705c-f655-472e-8732-eba57bedd7c6"> HSA's review of Swiss study </a> </li> </ul> </div> <div data-label="5dab3d87-61e1-4634-8e84-6de88ede8ef0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">E-services</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/e-services/eGIRO" data-guid="720bfe3e-013c-4a09-9e08-75de89fb0f39"> eGIRO </a> </li> </ul> </div> <div data-label="bd4d47da-3264-48f7-b788-f7ec3192566a" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Consumer safety</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="a42d2730-7835-4ae5-bf0e-f23171a903e5"> Articles </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/consumer-safety/make-a-report" data-guid="37e114c1-1313-478a-9456-ddf438abf2a3"> Make a report </a> </li> </ul> </div> <div data-label="47b22a70-25fc-4858-a0c6-5808f105461d" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Why join HSA</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/apply" data-guid="826776c8-7652-4790-8a89-486de533b723"> Apply for a job </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/sponsorship-for-diploma-in-nursing" data-guid="b43bd040-0e61-498c-b9a9-7f4200475fcb"> Diploma in Nursing Scholarship </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/benefits" data-guid="98fda3e9-d25c-4052-b385-b35110b6f3a3"> Employment benefits </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="adfe758d-5941-4ea6-baf1-69fa38b2a74e"> Articles </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/forensic-odontology-scholarship" data-guid="a3e7ab3f-c4cd-46a2-b1ab-89188e470964"> Forensic Odontology Scholarship </a> </li> </ul> </div> </div> <div class="hsa-header__sidebar__extender__column-2"> <div data-label="7ede8f61-ff1c-4c69-a6a4-df1fd414c539" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register your device</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/overview" data-guid="4a0a9bfd-e83f-4cac-ab82-30f548c7dfa0"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/is-it-a-medical-device" data-guid="0ddfe170-9c1e-44fc-8827-7c8a73854b0a"> Is it a medical device <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/risk-classification-rule" data-guid="f4fac194-4032-4e22-9ddc-5a0e214e4619"> Risk classification rules and factors </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/risk-classification" data-guid="2e0cc6ab-f76d-4b71-a4a9-3ab6b1fd473a"> Risk classification tool <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/requirements" data-guid="b9c4171b-7fb0-4b77-a8c8-d2479ec34896"> Registration and licensing requirements <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/identifying-md-grouping" data-guid="9dc2b5a8-f5fe-4cd2-80b1-a0af4a75a057"> Medical device grouping tool <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="4ab762eb-155b-466b-8a25-82bd36c8a446"> Grouping medical devices </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f2dbc2a3-5dd0-48e9-8050-6eefb4934da4"> Registration guides </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/priority-review-scheme" data-guid="aefddcf5-7ca3-43fc-b6c7-e7783239225d"> Priority Review Scheme </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="04b8be8f-e147-47dd-89b7-56c00dd52cdc"> Special Access Routes </a> </li> </ul> </div> <div data-label="30939644-bd18-43b4-b6d1-de9a663ccdb4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/apply" data-guid="471507f9-e42c-4931-a6e0-40b8fc7e39a6"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/amend-licence" data-guid="60791d45-21e2-4661-b9bd-a9c144e51de3"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/renew" data-guid="cafdc875-fc28-4b2d-bec3-eefb3cae23e4"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/good-distribution-practice" data-guid="570127a0-ec1a-4c01-8691-5c70cea0234e"> Good Distribution Practice for Medical Devices </a> </li> </ul> </div> <div data-label="668d06f0-a4bb-4de1-8caf-df59aed1ed04" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Field Safety Corrective Action reporting</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/when-to-report" data-guid="d24d93f8-8fb7-4b96-a2ca-7b5b777fe053"> When to report </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/how-to-report" data-guid="0db2317b-2b8e-47dd-8930-dbbd185b03ab"> How to report </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/corrective-actions" data-guid="f5468317-a7b2-4680-9177-0a6e01b7aa7d"> Risk management </a> </li> </ul> </div> <div data-label="27da00ef-00ec-4790-9d18-6916d678ecfd" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">International collaboration</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/international-collaboration-medical-devices/imdrf" data-guid="b0404985-fb75-4ba2-9984-890a03321340"> International Medical Device Regulators Forum (IMDRF) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/international-collaboration-medical-devices/amdc" data-guid="d61db71a-7a93-46ad-a667-9fcfe7566a68"> ASEAN Medical Device Committee (AMDC) </a> </li> </ul> </div> <div data-label="1bb793b7-6ebc-4614-ab26-f3486e8d47b8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register your product</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="87e8659d-45a2-40d7-9189-993d38a0633c"> Registration overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="e10dc8cc-ed64-45f7-b36b-4a3cde564f61"> Registration guides for therapeutic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/rmp" data-guid="7dd5cd91-7696-4034-9093-a95c3107c759"> RMP submission for product registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/ectd-submissions" data-guid="7b957570-e4b0-4284-8943-8d8071370815"> eCTD submissions for Therapeutic Products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/summary-reports-of-benefit-risk-assessment" data-guid="187939d4-5a68-4657-a077-e9d00bc5f99c"> Summary Reports of Benefit-Risk Assessment </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="6e925ab4-a2e4-4933-8edc-d51e50dafe86"> Special Access Routes (SAR) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/gmp-conformity-assessment" data-guid="171464e4-b6af-4d89-a1b6-c091f73f04a6"> GMP conformity assessment of overseas manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/vaccine-lot-release" data-guid="a7da8b5f-b675-48ea-ae81-fe833f29c17a"> Lot release for imported vaccines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/pre-submission-consultation-mechanisms" data-guid="d566e8c5-3a97-48bd-8d98-03674add1d28"> Pre-submission Consultation Mechanisms </a> </li> </ul> </div> <div data-label="382c3665-f125-4dbd-aa45-33855a4edecc" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Apply for post-approval variation</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/overview" data-guid="7740ca55-114c-40cc-b6b3-e0c70fe2a1fd"> Overview of variation application types </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="81f2aeb5-71fc-4437-bcbe-363566451aa3"> Major variation (MAV-1) application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/major-variation-(mav-2)-application" data-guid="6125cd60-e055-4946-a956-da4ee2b4002c"> Major variation (MAV-2) application </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="2309de76-0cee-4377-bc01-65f576892d9d"> Minor variation (MIV) application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv-tool" data-guid="4e9c7bc2-7929-421d-a639-ac4254fdc3b2"> Minor variation (MIV) self-guided tool </a> </li> </ul> </div> <div data-label="c7d36f32-24f2-4341-852f-879820bd2f95" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Reclassify your product</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/apply" data-guid="e17c9ffe-34d9-4e3d-9b76-f8928b998559"> Apply for reclassification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/gsl-preparations" data-guid="d0881b89-7e49-44cc-abbd-9c82ff224ce0"> Preparations allowed as General Sale List </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/list-of-reclassified-medicines" data-guid="3f4cdc7d-b9d6-44c4-baae-30ef723ff6c7"> List of reclassified medicines </a> </li> </ul> </div> <div data-label="610292f3-004d-4e6e-8995-c25be4a1273b" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/overview" data-guid="ff94a8de-0f52-4326-a3d0-904f94453385"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/apply" data-guid="acb36be4-f93e-43f3-9319-70da968ad961"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/amend" data-guid="899be1f3-552e-4269-99fe-a7615d0e9716"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/renew-cancel" data-guid="b093e7ef-4fe0-46e5-bcff-0f8c85b4e22a"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/gmp-gdp" data-guid="1a2c9571-60d0-4865-8bf1-46344bccb039"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="32be46d4-2acb-4aef-8f28-ebb7fb04cd48"> Certification of local dealers </a> </li> </ul> </div> <div data-label="25fc1ebe-32a2-4170-ae07-309d697d35e5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Retail pharmacy licensing</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/overview" data-guid="846633be-094f-4199-b920-c6531091efc8"> Overview of pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/apply" data-guid="f245d777-06aa-4348-a351-b85487c9ce55"> Apply for a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/amend" data-guid="1584bcc1-9336-4aa3-961a-d1c3f0032337"> Amend a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/renew" data-guid="0353546c-97e6-4d66-85c5-fe1e53963535"> Renew or cancel a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/compounding" data-guid="60098304-7263-4df6-a7c5-174b08dd82c0"> Compounding of therapeutic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/medicines-vending-machine" data-guid="7f972414-5cef-49a6-a1fd-f7ed0e4af21c"> Supply of medicines via vending machine </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/supply-of-registered-therapeutic-products-through-e-pharmacy" data-guid="828f1524-09e6-4ff9-ac6e-b088ec682eb6"> Supply of registered therapeutic products through e-pharmacy </a> </li> </ul> </div> <div data-label="efa56797-fabe-4d38-810f-4cd825fa6486" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/regulatory-overview" data-guid="e001496c-1ac0-48b7-ac9a-0a31e6d8b278"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/new-cta-or-ctn-submission" data-guid="11ae3c13-c8d9-4466-9994-18c749d46398"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/subsequent-submissions" data-guid="4d2246bc-01b6-4141-91e0-33d1223c966c"> Subsequent submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/good-clinical-practice-inspections" data-guid="553ade66-b060-42dc-baa9-56144a172d44"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/report-adverse-events" data-guid="af55b5df-88f7-4678-809f-23f4c2929fa2"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/product-development-consultation-tp" data-guid="27d291f9-ebf1-4608-8fa6-713085708fa4"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/conducting-clinical-trials" data-guid="fc3b622a-e44c-46d3-a383-a1018014ee3f"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/clinical-trials-register" data-guid="15ea591f-c5e0-4227-9b65-60994fc1f227"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/clinical-trials-statistics" data-guid="23cf3a53-6367-4294-b3b8-a0421d0c845f"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="c28d32cb-4d78-48ec-bb2a-e42249225222" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CPP and SLS</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/cpp-sls/certificate-pharmaceutical-product" data-guid="4c2bb65e-ba3d-494c-9146-a1af2bf5a198"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/cpp-sls/statement-of-licensing-status" data-guid="38b573be-688f-4201-bae1-05c3242f820f"> Statement of Licensing Status </a> </li> </ul> </div> <div data-label="669e5508-668c-45fb-b768-d34e6d5fef95" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">International collaboration</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/access" data-guid="cd88ddb0-067d-40e3-a481-170f88c6562d"> Access Consortium </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/project-orbis" data-guid="13772e92-b28e-436c-839f-f09eb40b5550"> Project Orbis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/ich" data-guid="6fcd302f-db44-4cd2-97d7-6bd73026c319"> ICH </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/icmra" data-guid="7f94f1c1-c820-47d8-859f-4167caf86943"> ICMRA </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/ASEAN-JA" data-guid="599f42c0-3f96-4fd7-8573-2c4c888d90b1"> ASEAN Joint Assessment Procedure </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/npra" data-guid="42edfb18-8f08-4681-8c21-0883fdae9267"> NPRA </a> </li> </ul> </div> <div data-label="9abfc5d0-f746-49d7-8c7e-f71d93c182a9" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Medicines quality and compliance monitoring</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="05c2a122-d4f6-4009-9b51-f2586b1974b7"> Nitrosamine impurities in medicines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/product-quality-surveillance-for-therapeutic-products" data-guid="5a600c68-25b2-4b36-884b-ac611a8fb77d"> Product Quality Surveillance for therapeutic products </a> </li> </ul> </div> <div data-label="dae1b05b-8161-4833-95a5-14b6eda06caf" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Product listing</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/apply" data-guid="d3dc33cb-72b6-455b-a4cc-bafecf04b9b4"> Apply for new product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/amend-or-cancel-product-listing" data-guid="8bf219a3-a0c3-4fa6-8e60-ac51232d435c"> Amend or cancel product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/transfer" data-guid="39b0a3ca-c3a5-4024-abd2-36f934846e6e"> Transfer product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/responsibilities" data-guid="b72ec571-5f19-455c-b014-d2328677ebb7"> Responsibilities of a CPM dealer </a> </li> </ul> </div> <div data-label="17eb371c-7d1b-4ff8-8586-9190c021a006" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/overview" data-guid="704fcd23-901e-42a2-86ab-b176e7424c86"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/apply" data-guid="8aa5c9d5-196a-40ee-8690-59b98a73ec58"> Apply for a Chinese Proprietary Medicine dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/amend" data-guid="eda2ba95-18d7-4d9e-94ea-44c92daadadf"> Amend a Chinese Proprietary Medicine dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/renew" data-guid="0f88825d-0b84-474c-8644-15b3717b89e2"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/gmp-gdp-standards" data-guid="44f1fe10-f257-442c-bf08-95ad59209e4d"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="ebc90580-c276-42ef-981f-bddebc7d94ba"> Certification of local dealers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/import-reexport" data-guid="7a0c8192-a52e-4086-80d3-e38c482c5e3b"> Import for re-export of Chinese Proprietary Medicines </a> </li> </ul> </div> <div data-label="b6ca1f1f-75c5-4537-be36-0505ef1d1b42" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Cosmetic product notification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/notification/submit" data-guid="9ad25a41-d9b6-4fc5-8810-f64f01981dd6"> Submit notification and re-notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/notification/amend" data-guid="2294cf3e-6181-44f9-a240-0f16af284bba"> Update or cancel notification </a> </li> </ul> </div> <div data-label="25429b7c-80af-4fa8-bf40-70f62681eb5f" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco licences</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="87ce5044-4900-4e2f-9bd0-9cd5157bbbc0"> Tobacco retail licence </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="62df10a0-59ba-444c-b39d-95df004b8e57"> Tobacco import and wholesale licence </a> </li> </ul> </div> <div data-label="8bf23c04-8c49-4780-b303-542f375a2b39" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register a Class 2 CTGTP</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="e920cf5a-92be-4b4a-8511-94e6d69e67e6"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/gmp-comformity-assessment" data-guid="2781f73d-34ef-415d-b7df-4b427e017ace"> GMP conformity assessment of overseas manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/rmp" data-guid="4a3724cf-da51-4f02-8c3e-0c66e3880d1e"> RMP submission for product registration </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="68687f1e-54ec-4c56-97ca-8a69652bc5ca"> Special Access Routes (SAR) </a> </li> </ul> </div> <div data-label="f1513b1d-d5e5-4eb6-aa96-ff39b5c36981" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/overview" data-guid="18185124-e2e4-4893-bc2d-24833390b73e"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/apply-licence" data-guid="467e86a7-6b65-4533-afe7-7bb2b6b6acf0"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/amend-licence" data-guid="bdc29b3b-28f0-4091-a3c7-e63b64d73625"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/renew-cancel-licence" data-guid="822e134d-17ba-4951-bb33-0420ca35d99b"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/gmp-gdp-standards" data-guid="04c2d289-a719-4cad-bffb-5eaac0928778"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f3731991-e630-4cde-85f6-a2b5a92caffd"> Certification of local dealers </a> </li> </ul> </div> <div data-label="0baf57d7-e63c-4c85-b702-a326bda7a2c4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/overview" data-guid="0531ad74-2289-4cea-a184-7a689f6d8671"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/apply-cta-ctn" data-guid="2d3c83f8-19ec-4568-9724-287712bced88"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/subsequent-submissions" data-guid="31160422-8263-4e27-bf3d-1defbd279d5d"> Subsequent submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/good-clinical-practice" data-guid="e3acb007-da0a-4179-be0b-34ef4e45a0db"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/adverse-events" data-guid="f58f6596-9749-417f-8bce-58b3cecf0c27"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/innovation-office" data-guid="9fb4cc8b-4401-4cf5-99a9-72dec47ed6c1"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/conducting" data-guid="cbc80f0e-71aa-4edb-8b75-8dbe089eccdd"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/clinical-trials-register" data-guid="223ce50c-7b0e-4b00-a1d2-69ec9fb45bad"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/statistics" data-guid="abe53f4d-bee9-45c6-aaaf-a596773a5bd1"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="f9b17351-9e31-4cbe-9368-89990285d3ab" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Licensing and certification of importers and wholesalers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/overview" data-guid="af581c62-35ff-4a88-aa2d-410310050739"> Overview of Importer's and Wholesaler's Licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/apply-licence" data-guid="f9204d51-b719-4cfa-b572-091a60a75d78"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/amend-licence" data-guid="c4fdf9a4-20de-40bf-9e9a-1359f42092c5"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/renew-or-cancel-licence" data-guid="17fb6e80-e86c-428a-8109-4dcb153d751e"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/gdp-standards" data-guid="e2576b18-4901-4a7a-825d-932ec7a782b8"> Good Distribution Practice Standards </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/gdp-certification" data-guid="01c2a80e-143d-450e-a8e0-c14c4c20c76b"> Good Distribution Practice certification </a> </li> </ul> </div> <div data-label="3115698c-9584-4b2a-980e-61f2f1ddce20" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Licensing and certification of manufacturers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/overview" data-guid="d145ce20-5d5c-4bad-8a8e-b9257abbcb24"> Overview of Manufacturer's Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/apply-licence" data-guid="706e3708-bef4-4e46-87e6-360c7e1e79b4"> Apply for a Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/amend-licence" data-guid="3cb8cda8-4999-4003-9679-3875e8f8faeb"> Amend a Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/renew-or-cancel-licence" data-guid="9d235845-a7a7-4e8e-a7f8-1d7e5819b4b4"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/gmp-certificate" data-guid="411905ea-c379-472b-b78d-5135499a0340"> Good Manufacturing Practice Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/inspection-of-manufacturers" data-guid="e98d79ba-d283-4e7e-8d0e-5a74e2150e6f"> Inspection of Manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/responsibilities" data-guid="719a6af7-8c3c-4024-9dde-565b1774865d"> Responsibilities of Manufacturers </a> </li> </ul> </div> <div data-label="8c5c2c4d-0e40-4323-a87e-b4a3f03a4c2b" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CTA, CTN or CTC submissions</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/apply-cta-ctn" data-guid="fd5a5cb0-e976-4737-8156-e4d7d89625c0"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/apply-ctc" data-guid="d881faa6-50b3-4e9a-b49f-c7e836f31927"> New CTC submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/subsequent-submissions" data-guid="8606a110-ffa7-48fd-b396-cee1a8c927f3"> Subsequent submissions </a> </li> </ul> </div> <div data-label="525bb14a-8f6c-4ea3-920d-8126125f5443" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Conducting clinical trials</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/principal-investigator" data-guid="09039b0a-e3c4-42c6-a479-256852c976f8"> Principal investigator </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/sponsor" data-guid="96af64b8-f78f-41a7-af9f-ebbeb3745c36"> Sponsor </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/informed-consent" data-guid="c32e93ea-aee8-4d3b-a7fb-7ddd1a03777d"> Informed consent </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/investigational-auxiliary-products" data-guid="d685bdff-7ee3-4fe3-9c5f-5e3da68cab65"> Investigational and auxiliary products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/investigator-site-file" data-guid="7d157444-ca14-4c71-9e7c-a70d6cfb25f6"> Investigator Site File </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/template-forms" data-guid="b86a54e6-d735-4935-9fd8-b5ec9c396afc"> Template forms </a> </li> </ul> </div> <div data-label="2dfb1261-9d74-487f-b59a-8f0c75330def" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Controlled drugs</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/apply" data-guid="09b0b42f-bb0e-4b88-87da-6217c20c9d79"> Apply for a controlled drugs licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/amend" data-guid="80363e35-b7c8-4fdd-89e5-1083b6cf44db"> Amend licence to wholesale or manufacture controlled drugs </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/renew" data-guid="b24dea71-b089-4f92-9965-b7267a6aeaa9"> Renew or cancel a licence </a> </li> </ul> </div> <div data-label="a42d2730-7835-4ae5-bf0e-f23171a903e5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Articles</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/consumer-safety/articles/details" data-guid="af2478a5-7fc1-470a-b80f-e1d62b156a71"> Details </a> </li> </ul> </div> <div data-label="adfe758d-5941-4ea6-baf1-69fa38b2a74e" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Articles</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/articles/details" data-guid="48176b72-3c3b-4b1d-9889-363953f7e2da"> Details </a> </li> </ul> </div> </div> <div class="hsa-header__sidebar__extender__column-3"> <div data-label="4ab762eb-155b-466b-8a25-82bd36c8a446" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Grouping medical devices</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/dental-grouping-terms"> Dental Grouping Terms (DGT) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/hearing-aids"> Hearing aids </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ihc-ivd"> Immunohistochemistry (IHC) IVD reagents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/fish-probes-ivd"> Fluorescence in situ hybridisation (FISH) probes IVD </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-analysers"> IVD analysers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivf-media"> In vitro fertilisation (IVF) media </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/family"> Family </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/system"> System </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/group"> Group </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/single"> Single </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-test-kit"> IVD Test Kit </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-cluster"> IVD cluster </a> </li> </ul> </div> <div data-label="f2dbc2a3-5dd0-48e9-8050-6eefb4934da4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration guides</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-full-registration"> Class B full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-abridged-registration"> Class B abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-immediate-registration"> Class B immediate registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-full-registration"> Class C full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-abridged-registration"> Class C abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-expedited-registration"> Class C expedited registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-immediate-registration"> Class C immediate registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-full-registration"> Class D full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-abridged-registration"> Class D abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-expedited-registration"> Class D expedited registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-medicinal-products-full-registration"> Class D with a registrable drug in a secondary role full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration"> Class D with registrable drug in secondary role abridged registration </a> </li> </ul> </div> <div data-label="04b8be8f-e147-47dd-89b7-56c00dd52cdc" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/export"> Import for re-export of unregistered devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/non-clinical-purpose"> Unregistered devices for non-clinical purposes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/consignment-registered"> Registered medical devices on consignment basis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/qualified-practitioner-request"> Unregistered devices requested by qualified practitioners </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/phmc-request"> Unregistered devices requested by licensed healthcare facility </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/custom-made-devices"> Custom-made medical devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/import-unregistered-devices-exhibition"> Import of unregistered medical devices for exhibition </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/import-of-unregistered-pre-owned-devices-returned-from-maintenance-repair"> Import of unregistered pre-owned devices from maintenance/repair </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/PSAR-MD"> PSAR for Supply of Emergency Medical Devices </a> </li> </ul> </div> <div data-label="87e8659d-45a2-40d7-9189-993d38a0633c" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration overview</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/overview"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/application-types"> Application types </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/evaluation-routes"> Evaluation Routes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/application-dossier"> Application dossier </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/screening-evaluation"> Screening and evaluation stages </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/retain-cancel-transfer"> Retain, cancel or transfer registrations </a> </li> </ul> </div> <div data-label="e10dc8cc-ed64-45f7-b36b-4a3cde564f61" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration guides for therapeutic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/new-drug"> New drug application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/generic-drug"> Generic drug application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/biosimilar-products"> Biosimilar product application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/drug-master-file"> Submission of Drug Master File </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/plasma-master-file"> Submission of Plasma Master File </a> </li> </ul> </div> <div data-label="6e925ab4-a2e4-4933-8edc-d51e50dafe86" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes (SAR)</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/import-for-patients"> Import and supply of unregistered TP for patient's use </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/consignment-registered"> Import and supply of registered drug on consignment basis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/special-consignment-by-a-product-registrant"> Special consignment by a product registrant </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/psar-emergency-therapeutic-product"> Pandemic Special Access Route for Supply of Emergency TP </a> </li> </ul> </div> <div data-label="81f2aeb5-71fc-4437-bcbe-363566451aa3" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Major variation (MAV-1) application</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/overview"> Overview of MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/full-evaluation"> Full evaluation route for MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/abridged-evaluation"> Abridged evaluation route for MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/verification-evaluation"> Verification evaluation route for MAV-1 application </a> </li> </ul> </div> <div data-label="2309de76-0cee-4377-bc01-65f576892d9d" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Minor variation (MIV) application </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv/overview"> Overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv/submission"> Submit MIV applications </a> </li> </ul> </div> <div data-label="32be46d4-2acb-4aef-8f28-ebb7fb04cd48" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/certificates/gmp-certificate"> Good Manufacturing Practice certificate for local manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/certificates/gdp-certificate"> Good Distribution Practice certificate for local dealers </a> </li> </ul> </div> <div data-label="05c2a122-d4f6-4009-9b51-f2586b1974b7" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Nitrosamine impurities in medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/list-of-impacted-medicines"> List of impacted medicines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/guidance-for-product-registrants"> Guidance for product registrants </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/test-methods"> Test methods </a> </li> </ul> </div> <div data-label="ebc90580-c276-42ef-981f-bddebc7d94ba" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/certification-of-local-manufacturers/gmp-certificate"> Good Manufacturing Practice certificate for local manufacturers </a> </li> </ul> </div> <div data-label="87ce5044-4900-4e2f-9bd0-9cd5157bbbc0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco retail licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/apply"> Apply for a tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/amend"> Amend tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/renew"> Renew tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/cancel"> Cancel tobacco retail licence </a> </li> </ul> </div> <div data-label="62df10a0-59ba-444c-b39d-95df004b8e57" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco import and wholesale licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/apply"> Apply for tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/amend"> Amend tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/renew"> Renew tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/cancel"> Cancel tobacco import and wholesale licence </a> </li> </ul> </div> <div data-label="e920cf5a-92be-4b4a-8511-94e6d69e67e6" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration overview</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/overview"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/application"> Application submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/pmc"> Pre-market consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/screening-evaluation-rd"> Screening, evaluation and regulatory decision </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/retain-cancel-transfer"> Retain, cancel or transfer registrations </a> </li> </ul> </div> <div data-label="68687f1e-54ec-4c56-97ca-8a69652bc5ca" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes (SAR)</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/sar/unregistered-CTGTP"> Import and supply of unregistered Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/sar/registered-ctgtp-on-consignment-basis"> Import and supply of CTGTP on consignment basis </a> </li> </ul> </div> <div data-label="f3731991-e630-4cde-85f6-a2b5a92caffd" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/certification/gmp-certification"> Good Manufacturing Practice certificate for local manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/certification/gdp-certification"> Good Distribution Practice certificate for local dealers </a> </li> </ul> </div> </div> </div> </aside> <div class="hsa-header__overlay"></div> </header> <nav class="hsa-nav"> <div class="hsa-nav__navbar"> <button class="hsa-nav__menu-btn" type="button" aria-controls="navigation-sidebar" aria-label="sidebar_menu-btn"> <span class="hsa-hamburgers m-r:xs"><span class="hsa-hamburgers__lines"></span> </span> <span class="hsa-nav__menu-btn__text">Browse</span> </button> <div class="hsa-breadcrumbs m:0"> <ol> <li><a href="/">Home </a></li> <li><a href="/clinical-trials">Clinical trials </a></li> </ol> <div class="hsa-breadcrumbs__crumb-dropdown"> <ul> </ul> </div> </div> <button class="hsa-font-decrease ldsk(d:n)" type="button"><span class="hsa-glyphs--Aminus"></span> <span class="fz:0">Decrease font size</span></button> <button class="hsa-font-increase ldsk(d:n)" type="button"><span class="hsa-glyphs--Aplus"></span> <span class="fz:0">Increase font size</span></button> <button class="hsa-nav__search-btn" type="button" aria-label="search-btn"><span class="hsa-glyphs--search"></span> <span class="hsa-nav__search-btn__text">Search</span></button> <button class="hsa-nav__back-btn" type="button"><span class="hsa-glyphs--chevron-left"></span> <span class="hsa-nav__back-btn__text">Back</span></button> </div> </nav> <main id="content" class="flg:1 bgc:grey-6 z:1" role="main"> <div class="container p-t:4xl p-b:4xl"> <div class="g:12"> <div class="gcol:12 dsk(gcol:8) ord:1"> <div id="main_TB6F372E3007_Col00" class="sf_colsIn" data-sf-element="title" data-placeholder-label="title"> <h1>Conducting clinical trials</h1> <ol class="hsa-guided-toc" style="display: grid; grid-template-rows: 2fr 2fr;"> <li><div><a href="/clinical-trials/conducting/principal-investigator" target="_self">Principal Investigator</a></div></li> <li><div><a href="/clinical-trials/conducting/sponsor" target="_self">Sponsor</a></div></li> <li><div><a href="/clinical-trials/conducting/informed-consent" target="_self">Informed consent</a></div></li> <li><div><a href="/clinical-trials/conducting/investigational-auxiliary-products" target="_self">Investigational and auxiliary products</a></div></li> <li><div><a href="/clinical-trials/conducting/investigator-site-file" target="_self">Investigator Site File</a></div></li> <li><span class="active">Template forms</span></li> </ol> <h1>Template forms</h1> <p class="hsa-text--summary">Refer to this list of template forms to assist you in conducting clinical trials. </p> </div> <div id="main_TB6F372E3007_Col01" class="sf_colsIn" data-sf-element="content" data-placeholder-label="content"> <div > <div ><h2>Overview </h2> <p> The following list of template forms have been compiled from best practices noted from Good Clinical Practice Inspections conducted to date. </p> <p> You may also choose not to use these templates if you have suitable alternatives available. </p> <h3> Disclaimer </h3> <p> These template forms are issued by HSA solely for the purpose of facilitating the conduct of your clinical trial. If necessary, customise these template forms to suit the needs of your clinical trial. </p> <p> These template forms are provided on an "as is basis" for use at your own risk and without warranties of any kind. To the fullest extent permitted by law, HSA does not warrant and hereby disclaims all express, implied and statutory warranties of any kind to you or any third party whether arising from usage, custom, trade or by operation of law or otherwise, including but not limited to the following: </p> <ol> <li>Any representations or warranties as to the accuracy, correctness, reliability, timeliness, non-infringement, title, merchantability or fitness for any particular purpose of the template forms; and </li> <li>Any representations or warranties that the template forms will be error-free or that errors will be corrected. </li> </ol> <p> HSA will not be liable to you or any third party for any loss or damage whatsoever including but not limited to direct, indirect, punitive, special or consequential damages, loss of income, revenue or profits, lost or damaged data, or damage to your computer, software, modem, telephone or other property, arising directly or indirectly from either of the following: </p> <ul> <li>Accessing or using the template forms</li> <li>Relying on any statements, opinions, representations or information in the template forms</li> <li>Any decision, conduct or the views of any person taken in reliance on the contents of the template forms</li> </ul> <p> It remains the responsibility of the sponsor and investigator to implement and maintain quality assurance and quality control systems to ensure that clinical trials are conducted in compliance with the protocol, standard operating procedures, Good Clinical Practice and applicable regulatory requirements. </p> <p> HSA will not be in a position to review sponsor and site SOPs. In the event if you have any clarifications on the template forms, please submit an enquiry to <a title="Email HSA_CT@hsa.gov.sg" href="mailto:HSA_CT@hsa.gov.sg">HSA_CT@hsa.gov.sg</a>. </p> <h2> Templates </h2></div> </div> <div id="main_C003_Col00" class="sf_colsIn hsa-toggle hsa-card p:0" data-sf-element="Toggle" data-placeholder-label="Toggle"><div id="main_C004_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Investigational Product (IP) templates</h1> <table> <thead> <tr> <th> Template form </th> <th> Description </th> </tr> </thead> <tbody> <tr> <td><a title="IP Management SOP" href="/docs/default-source/hprg-io-ctb/template-forms/investigational-product-management-sop-template_5feb2021.doc?sfvrsn=ddeee9f9_2">IP Management SOP<em class="hsa-glyphs--doc"></em><span>99 KB</span></a><br /> </td> <td> This SOP template could be used to provide written instructions to guide the site staff on the management of IP at site. It includes instructions to ensure proper receipt, storage, repackaging, dispensing, accountability, return and destruction of the IP.<br /> <br /> Useful tips:<br /> <ul> <li>Roles and responsibilities of the blinded and unblinded study teams should be clearly segregated. </li> <li>Site staff should be delegated on the Signature Sheet. </li> </ul> <p> Applicable references: GCP 5.14.3 </p> </td> </tr> <tr> <td><a title="IP Inventory Log (without individual kit number)" href="/docs/default-source/hprg-io-ctb/template-forms/ip-inventory-log-template_without-individual-kit-numbers_5feb2021.doc?sfvrsn=aa831a38_2">IP Inventory Log (without individual kit number)<em class="hsa-glyphs--doc"></em><span>57 KB</span></a><br /> </td> <td> This template could be used to document the inventory of the IP at the site, taking into consideration the amount of IP received at site and dispensed to trial participants.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Check the physical inventory against the IP Inventory Log on a regular basis. </li> <li>The IP Inventory Log should not be completed electronically, unless the inventory is managed by a validated electronic system. </li> </ul> <br /> Applicable references: GCP 4.6.3<br /> </td> </tr> <tr> <td><a title="IP Inventory Log (with individual kit number)" href="/docs/default-source/hprg-io-ctb/template-forms/ip-inventory-log-template_with-individual-kit-numbers_5feb2021.doc?sfvrsn=5a31a3f9_2">IP Inventory Log (with individual kit number)<em class="hsa-glyphs--doc"></em><span>56 KB</span></a><br /> </td> <td> This template could be used to document the inventory of treatment kits at the site, taking into consideration the treatment kits received at site and dispensed to trial participants.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Check the physical inventory against the IP Inventory Log on a regular basis. </li> <li>The IP Inventory Log should not be maintained electronically, unless the inventory is completed by a validated electronic system. </li> </ul> <br /> Applicable references: GCP 4.6.3 </td> </tr> <tr> <td><a title="IP Inventory Log (with IP repackaging done at site)" href="/docs/default-source/hprg-io-ctb/template-forms/ip-inventory-log-template_with-ip-repackaging-done-at-site_5feb2021.doc?sfvrsn=2a8f3803_2">IP Inventory Log (with IP repackaging done at site)<em class="hsa-glyphs--doc"></em><span>58 KB</span></a><br /> </td> <td> This template could be used at sites where IP repackaging is done to blind the study treatment. It should be used by the unblinded study team to document the inventory of the bulk IP received from sponsor, repacked and transferred to the blinded team.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP repackaging should be part of an unblinded study team. </li> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Separate IP Inventory Logs should be maintained for each IP. </li> <li>The IP Inventory Log should be filed in the Pharmacy Binder, where access is secure and limited to the unblinded study team in order to maintain the study blind. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Check the physical inventory against the IP Inventory Log on a regular basis. </li> <li>The IP Inventory Log should not be completed electronically, unless the inventory is managed by a validated electronic system. </li> <li>All correspondences concerning IP Management that may potentially unblind the study should be limited to the unblinded study team. </li> </ul> <p> Applicable references: GCP 4.6.3 </p> </td> </tr> <tr> <td> IP Dispensing and Accountability Log Template:<br /> <ul> <li><a title="With individual kit numbers" href="/docs/default-source/hprg-io-ctb/template-forms/ipal-template_with-individual-kit-numbers_5feb2021.doc?sfvrsn=5c595e8f_2">With individual kit numbers<em class="hsa-glyphs--doc"></em><span>55 KB</span></a></li> <li><a title="Without individual kit numbers" href="/docs/default-source/hprg-io-ctb/template-forms/ipal-template_without-individual-kit-numbers_5feb2021.doc?sfvrsn=9338b29c_2">Without individual kit numbers<em class="hsa-glyphs--doc"></em><span>55 KB</span></a></li> </ul> </td> <td> This template could be used to document the accountability of the IP received at the site, dispensed to trial participants and returned to site. It serves to ensure that the IP has been used according to the protocol.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Check the physical inventory against the IP Inventory Log on a regular basis. </li> <li>The IP Dispensing and Accountability Log should not be completed electronically, unless the inventory is managed by a validated electronic system. </li> </ul> Applicable references: GCP 4.6.3, 4.6.5<br /> </td> </tr> <tr> <td><a title="IP Dispensing and Accountability Log (with IP repackaging done at site)" href="/docs/default-source/hprg-io-ctb/template-forms/ipal-template_with-ip-repackaging-done-at-site_5feb2021.doc?sfvrsn=bca9aae1_2">IP Dispensing and Accountability Log (with IP repackaging done at site)<em class="hsa-glyphs--doc"></em><span>58 KB</span></a><br /> </td> <td> This template could be used at sites where IP repackaging is done to blind the study treatment. It should be used by the blinded team to document the accountability of the repackaged IP received from unblinded study team, dispensed to trial participants, returned to site by trial participants, and returned to unblinded study team. This template serves to ensure that the IP have been used according to the protocol.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP repackaging should be part of an unblinded study team. </li> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Check the physical inventory against the IP Inventory Log on a regular basis. </li> <li>The IP Dispensing and Accountability Log should not be completed electronically, unless the inventory is managed by a validated electronic system. </li> </ul> Applicable references: GCP 4.6.3, 4.6.5<br /> </td> </tr> <tr> <td><a title="IP Repackaging and Relabelling Form" href="/docs/default-source/hprg-io-ctb/template-forms/ip_repackaging_and_relabelling_form_template_1nov2016.doc?sfvrsn=3598191b_0">IP Repackaging and Relabelling Form<em class="hsa-glyphs--doc"></em><span>95 KB</span></a><br /> </td> <td> This template could be used at sites where IP repackaging is done to blind the study treatment. It should be used by the unblinded team to document the IP repackaging and relabelling process, and serves to ensure that the process is conducted in accordance to GMP guidelines.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP repackaging should be part of an unblinded study team. </li> <li>Ensure there are written procedures available for IP Repackaging and Relabelling. </li> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Site staff involved in IP Repackaging and Relabelling should be trained accordingly. </li> <li>A witness, who is part of the unblinded study team, should observe the IP Repackaging and Relabelling process. </li> <li>Line clearance should be observed such that one type of IP is repackaged and relabelled at a time to avoid any mix up. </li> <li>The quantity of the IP labels should be reconciled and documented on the IP Repackaging and Relabelling Form. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>The IP Inventory Logs should be updated for IP Repackaging and Relabelling. </li> <li>The IP Repackaging and Relabelling Form should be filed in the Pharmacy Binder, where access is secure and limited to the unblinded study team in order to maintain the study blind. </li> <li>All correspondences concerning IP Management that may potentially unblind the study should be limited to the unblinded study team. </li> <li>The IP Repackaging and Relabelling Form should not be completed electronically. </li> </ul> Applicable references: PICS Annex 13<br /> </td> </tr> <tr> <td> <a title="IP Destruction Form" href="/docs/default-source/hprg-io-ctb/template-forms/ip_destruction_form_template_dec2014.doc?sfvrsn=80007133_0">IP Destruction Form<em class="hsa-glyphs--doc"></em><span>65 KB</span></a></td> <td> This template could be used to document the destruction of returned/ unused IP by the sponsor or site.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>The IP meant for destruction should be kept separately from the unused IP. </li> <li>The IP Destruction Form should not be maintained electronically, unless the inventory is completed by a validated electronic system. </li> </ul> Applicable references: GCP 4.6.3<br /> </td> </tr> <tr> <td><a title="IP Storage Temperature Log" href="/docs/default-source/hprg-io-ctb/template-forms/ip_storage_temperature_log_template_dec2014.doc?sfvrsn=47233e5c_0">IP Storage Temperature Log<em class="hsa-glyphs--doc"></em><span>68 KB</span></a><br /> </td> <td> This template could be used to record the IP storage temperature. It serves to document that the IP is stored according to the protocol.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Ensure that the thermometer used for monitoring the IP storage temperature is calibrated and maintained regularly. Copies of the calibration and maintenance records should be filed in the Investigator Site File. </li> <li>Record the serial number of the thermometer on the IP Storage Temperature Log for traceability purposes. </li> </ul> Applicable references: 4.6.4<br /> </td> </tr> <tr> <td><a title="IP Storage Temperature Excursion Report" href="/docs/default-source/hprg-io-ctb/template-forms/ip-storage-temperature-excursion-report-template_5feb2021.doc?sfvrsn=42f15d6f_2">IP Storage Temperature Excursion Report<em class="hsa-glyphs--doc"></em><span>85 KB</span></a></td> <td> This template could be used to report any deviation in the IP storage temperature to sponsor. It documents the details of the deviation and the response by sponsor.<br /> <br /> Useful tips:<br /> <ul> <li>Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> </ul> Applicable references: GCP 4.6.4</td> </tr> </tbody> </table></div> </div> </div><div id="main_C005_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Investigator Site File (ISF) templates</h1> <table> <thead> <tr> <th>Template form</th> <th>Description</th> </tr> </thead> <tbody> <tr> <td><a title="Investigator Site File Content Page" href="/docs/default-source/hprg-io-ctb/template-forms/investigator_site_file_contents_page_5feb2021.docx?sfvrsn=119afcec_2">Investigator Site File Contents Page<em class="hsa-glyphs--doc"></em><span>44 KB</span></a></td> <td> This template could be used to establish the Investigator Site File at the beginning of the trial. It contains the minimum list of essential documents which should be maintained for the clinical trial.<br /> <br /> Useful tips:<br /> <ul> <li>Superseded essential documents (e.g. protocol, Investigator’s Brochure, Informed Consent Form templates) should not be removed from the Investigator Site File. A copy of the superseded essential documents should be marked ‘Superseded’ and retained in the Investigator Site File. </li> <li>A note to file should be placed in the relevant section of the Investigator Site File if the essential document has been filed elsewhere. </li> <li>Check that all essential documents are complete, accurate, legible and current. </li> </ul> <p> Applicable references: GCP 4.9.5, Section 8 </p> </td> </tr> <tr> <td><a title="Protocol Signature Page" href="/docs/default-source/hprg-io-ctb/template-forms/protocol_signature_page_template_1nov2016.docx?sfvrsn=f567ac37_0">Protocol Signature Page<em class="hsa-glyphs--doc"></em><span>13 KB</span></a></td> <td> This template could be used to document the Investigator's agreement to the protocol and its amendments.<br /> <br /> Useful tips:<br /> <ul> <li>Signed protocol signature pages should be present for the approved protocol and subsequent amendments used at the site. </li> </ul> Applicable references: GCP 4.5.1, 8.2.2<br /> </td> </tr> <tr> <td><a title="Trial Participant Identification Log" href="/docs/default-source/hprg-io-ctb/template-forms/trial-participant-identification-log_5feb2021.docx?sfvrsn=11f38964_2">Trial Participant Identification Log<em class="hsa-glyphs--doc"></em><span>31 KB</span></a></td> <td> This template could be used to document the names of all trial participants enrolled in the trial.<br /> <br /> Useful tips:<br /> <ul> <li>The Trial Participant Identification Log is a confidential document that should be maintained in the Investigator Site File. It should not be circulated to the Sponsor, IRB, HSA or other third parties. </li> <li>Ensure that the Trial Participant Identification Log is updated in a timely manner whenever a new trial participant is enrolled into the clinical trial. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> </ul> <p> Applicable references: GCP 8.3.21 </p> </td> </tr> <tr> <td><a title="Trial Participant Screening and Enrolment Log" href="/docs/default-source/hprg-io-ctb/template-forms/trial-participant-screening-and-enrollment-log_5feb2021.docx?sfvrsn=b06d1d82_2">Trial Participant Screening and Enrolment Log<em class="hsa-glyphs--doc"></em><span>34 KB</span></a></td> <td> This template could be used to track the visit schedules for enrolled trial participants. It serves to assist the site in ensuring that the trial participants complete their study visits timely in accordance to the protocol.<br /> <br /> Useful tips:<br /> <ul> <li>Ensure that the log is updated in a timely manner whenever there is a new trial participant screened or enrolled into the trial. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> </ul> <p> Applicable references: GCP 8.3.20, 8.3.22 </p> </td> </tr> <tr> <td><a title="Trial Participant Visit Schedule Log" href="/docs/default-source/hprg-io-ctb/template-forms/trial-participant-visit-schedule-log_5feb2021.docx?sfvrsn=fc769bbd_2">Trial Participant Visit Schedule Log<em class="hsa-glyphs--doc"></em><span>35 KB</span></a></td> <td> This template could be used to track the visit schedules for enrolled trial participants. It serves to assist the site in ensuring that the trial participants complete their study visits timely in accordance to the protocol.<br /> <br /> Useful tips:<br /> <ul> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> </ul> </td> </tr> <tr> <td><a title="Signature Sheet" href="/docs/default-source/hprg-io-ctb/template-forms/signature-sheet_5feb2021.docx?sfvrsn=b10a2a63_2">Signature Sheet<em class="hsa-glyphs--doc"></em><span>37 KB</span></a></td> <td> This template could be used to document the roles, responsibilities and signatures of all site staff who have been authorised by the Principal Investigator to conduct trial-related duties.<br /> <br /> Useful tips:<br /> <ul> <li>The Principal Investigator should ensure that the site staff is adequately qualified by education, training and experience to perform the delegated duties. </li> <li>Site staff should be appropriately trained prior to conducting any study procedures. </li> <li>Sub-investigators should only be included in the study team after written IRB approval has been sought. </li> <li>It would be recommended that the trial-related activity of obtaining informed consent be delegated to an investigator who is a qualified practitioner or qualified pharmacist, adequately qualified by education, training and experience to determine the trial participant's eligibility for enrolment into the clinical trial and address any questions that the trial participant may have in a satisfactory manner. </li> <li>The Signature Sheet should be updated in a timely manner whenever there is a change to site staff or delegated duties. </li> <li>The name, initials and signature of the site staff on the Signature Sheet should be consistent with all other essential documents. </li> <li>In the event of a change in Principal Investigator during the course of a clinical trial, it would be recommended to update the previously signed Signature Sheet with an end date for each site staff, and to complete a new Signature Sheet for the new Principal Investigator to authorise the site staff. </li> <li>All versions, including superseded versions, should be present in the site file. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> </ul> <p> Applicable references: </p> <ul> <li>Regulation 23(3) of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations </li> <li>GCP 2.8, 4.1.5, 4.2.4, 4.9.1, 8.3.24 </li> </ul> </td> </tr> <tr> <td><a title="Site Training Log" href="/docs/default-source/hprg-io-ctb/template-forms/training_log_dec2014.docx?sfvrsn=98b70f4e_0">Site Training Log<em class="hsa-glyphs--doc"></em><span>24 KB</span></a></td> <td> This template could be used to document the training received by site staff, so as to ensure that the site staff are adequately qualified to conduct trial-related procedures.<br /> <br /> Useful tips:<br /> <ul> <li>Training records for all site staff delegated in the Signature Sheet should be present in the site file. </li> <li>It would be recommended to file the following training documentation for all site staff in the Investigator Site File, where applicable: <ul> <li>Investigator Meeting </li> <li>Site Initiation Visit </li> <li>Collaborative IRB Training Initiative (CITI) </li> <li>Good Clinical Practice (GCP) </li> <li>Protocol-specific training </li> </ul> </li> </ul> Applicable references: GCP 2.8, 4.2.4<br /> </td> </tr> <tr> <td><a title="Serious Adverse Event (SAE) Tracking Log" href="/docs/default-source/hprg-io-ctb/template-forms/serious-adverse-event-tracking-log_5feb2021.docx?sfvrsn=48e6bf8_2">Serious Adverse Event (SAE) Tracking Log<em class="hsa-glyphs--doc"></em><span>34 KB</span></a></td> <td> This template could be used to track the occurrence of serious adverse event (SAE) at site and the notification by site to IRB and HSA of the SAE and related reports.<br /> <br /> Useful tips:<br /> <ul> <li>Ensure that the safety reporting requirements are detailed in the protocol. </li> <li>Ensure that SAEs are notified to the Sponsor, IRB and HSA (where applicable) in accordance with their respective safety reporting requirements. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Ensure that the SAE Tracking Log is updated in a timely manner. </li> </ul> <p> Applicable references: </p> <ul> <li>Regulations 24 and 25 of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations </li> <li>GCP 2.3, 4.11, 5.16, 5.17, 8.3.16-18 </li> </ul> </td> </tr> <tr> <td><a title="Regulatory Document Tracking Log" href="/docs/default-source/hprg-io-ctb/template-forms/regulatory_document_tracking_log_dec2014.docx?sfvrsn=59adcf0b_0">Regulatory Document Tracking Log<em class="hsa-glyphs--doc"></em><span>28 KB</span></a></td> <td> This template could be used to track the submission and approval status of study documents submitted to IRB and HSA. It serves to assist the site in ensuring that study documents are implemented only after appropriate approval has been obtained accordingly.<br /> <br /> Useful tips:<br /> <ul> <li>Always check that the required approval for the study documents had been obtained prior to using them at site. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Ensure that the log is updated in a timely manner. </li> </ul> <p> Applicable references: GCP 4.4.1, 4.4.3 </p> </td> </tr> <tr> <td><a title="Non-compliance Tracking Log" href="/docs/default-source/hprg-io-ctb/template-forms/non-compliance-tracking-log_5feb2021.docx?sfvrsn=82e0fbf9_2">Non-compliance Tracking Log<em class="hsa-glyphs--doc"></em><span>30 KB</span></a></td> <td> This template could be used to track serious breaches and other non-compliances in the clinical trial.<br /> <br /> Useful tips:<br /> <ul> <li>Serious breaches of the principles of GCP or trial protocol or clinical trials regulations must be notified to HSA.</li> <li>A serious breach is a deviation which is likely to affect to a significant degree: (a) the safety or physical or mental integrity of any trial participants in a clinical trial, or (b) the scientific value of the clinical trial.</li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Ensure that the log is updated in a timely manner. </li> </ul> Applicable references:<br /> <ul> <li>Regulation 11 of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations </li> <li>GCP 4.5.3 </li> </ul> </td> </tr> <tr> <td><a title="Informed Consent Tracking Log" href="/docs/default-source/hprg-io-ctb/template-forms/informed-consent-tracking-log_5feb2021.docx?sfvrsn=67a6ff09_2">Informed Consent Tracking Log<em class="hsa-glyphs--doc"></em><span>29 KB</span></a></td> <td> This template could be used to track the versions of the informed consent forms which have been signed by trial participants.<br /> <br /> Useful tips:<br /> <ul> <li>Always check that trial participants have been consented with the latest approved informed consent form in a timely manner. </li> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Ensure that the log is updated whenever an informed consent form is signed. </li> </ul> </td> </tr> <tr> <td><a title="Biological Sample Handling Log" href="/docs/default-source/hprg-io-ctb/template-forms/biological-sample-handling-log_5feb2021.docx?sfvrsn=1cd6f75e_2">Biological Sample Handling Log<em class="hsa-glyphs--doc"></em><span>31 KB</span></a></td> <td> This template could be used to document the location and identification of the retained biological samples, as well as the accountability of the samples collected from trial participants and shipped to sponsor.<br /> <br /> Useful tips:<br /> <ul> <li>Amendments should be initialled and dated, and not obscured by overwriting or using correction tape. </li> <li>Ensure that the log is updated in a timely manner. </li> </ul> <p> Applicable references: GCP 8.3.25</p> </td> </tr> </tbody> </table></div> </div> </div> </div> <div class="hsa-section-navigator"> <a class="hsa-section-navigator__btn var--left" href="/clinical-trials/conducting/investigator-site-file"> <span class="hsa-section-navigator__btn-navigate"> <span class="hsa-glyphs--arrow-left"></span> <span class="hsa-section-navigator__btn-navigate-text">Previous</span> </span> <span class="hsa-section-navigator__btn-link"> <span>Investigator Site File</span> </span> </a> </div></div> </div> </div> <div class="g:12"> <div class="gcol:12 dsk(gcol:8)"> <div class="p-t:2xl m-b:2xl"> <div id="main_TB6F372E3007_Col02" class="sf_colsIn" data-sf-element="date updated" data-placeholder-label="date updated"> <time class="hsa-text--small m:0 p:0" datetime="2018-10-31" id="pageUpdatedTime">Last updated: <span id="pageUpdated">31 Dec 2018</span></time> <script> var pageTitle = document.title; $(document).ready(function () { $.getJSON('/GetPageModified/' + pageTitle, function (x) { var timeElement = document.getElementById("pageUpdatedTime"); if (timeElement) { timeElement.setAttribute("datetime", x.DateTime); document.getElementById("pageUpdated").textContent = x.DateTimeStr; } }); }); </script></div> <div id="main_TB6F372E3007_Col03" class="sf_colsIn hsa-share" data-sf-element="hsa share" data-placeholder-label="hsa share"> <span class="hsa-share__text" style="color:#667075">Share </span> <a href="http://facebook.com/sharer.php?u=" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="facebook-share-icon"> <span class="hsa-glyphs--social-facebook fz:2xl m-x:2xs" style="color:#3b5998"></span> </a> <a href="https://twitter.com/intent/tweet?text=Template forms:" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="twitter-share-icon"> <span class="hsa-glyphs--twitter fz:2xl m-x:2xs" style="color:#55acef"></span> </a> <a href="https://www.linkedin.com/sharing/share-offsite/?url=" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="linkedin-share-icon"> <span class="hsa-glyphs--linkedin fz:2xl m-x:2xs" style="color:#55acef"></span> </a> <a href="https://api.whatsapp.com/send/?text=Template forms:" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="whatsapp-share-icon"> <span class="hsa-glyphs--whatsapp fz:2xl m-x:2xs" style="color:#55acef"></span> </a> <a href="mailto:?subject=Template forms&body=" class="type--inherit hsa-embed-page-link" aria-label="mail-share-icon"> <span class="hsa-glyphs--social-mail fz:2xl m-x:2xs c:yellow-1"></span> </a> <a href="#" class="type--inherit hsa-print" aria-label="print-icon"> <span class="hsa-glyphs--print fz:2xl m-x:2xs c:blue-1"></span> </a></div> </div> </div> </div> </div> <section id="main_TB6F372E3007_Col04" class="sf_colsIn hsa-topic-explorer" data-sf-element="hsa topic explorer" data-placeholder-label="hsa topic explorer" role="navigation"> <div class="container"> <div class="hsa-toc var--end-cog"> <h3 class="hsa-text--h2 p-t:0 m-b:l"> <a href="/clinical-trials" class="type--inherit">Clinical trials</a> </h3> <ul> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/overview">Regulatory overview</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/application">CTA, CTN or CTC submissions</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/crm-notification">Submit a CRM notification</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/good-clinical-practice">Good Clinical Practice Inspections</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/adverse-events">Report adverse events</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/innovation-office">Innovation Office</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/conducting">Conducting clinical trials</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/participating">Participating in clinical trials</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/regulatory-guidances">Guidance documents</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/clinical-trials-register">Clinical Trials Register</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/statistics">Clinical trials statistics</a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/prism/clinical-trials">PRISM (Clinical trials) </a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/infosearch">Infosearch</a> </p> </li> </ul> </div> </div> <div class="hsa-sticky-topic-explorer" data-active="false" style="top: inherit; bottom: -464px;"> <button class="hsa-sticky-topic-explorer__btn" type="button" style="order: 1;"> Content in this section <span class="hsa-sticky-topic-explorer__btn__action"> <span class="hsa-sticky-topic-explorer__btn__action__text">show</span> <span class="c:blue-1 hsa-glyphs--chevron-up" style="transform: rotate(0deg);"></span> </span> </button> <div class="hsa-sticky-topic-explorer__content container" style="order: 2; opacity: 0;"> <div class="hsa-toc var--end-cog"> <h3 class="hsa-text--h2 p-t:0 m-b:l"> <a href="/clinical-trials" class="type--inherit">Clinical trials</a> </h3> <ul> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/overview">Regulatory overview</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/application">CTA, CTN or CTC submissions</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/crm-notification">Submit a CRM notification</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/good-clinical-practice">Good Clinical Practice Inspections</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/adverse-events">Report adverse events</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/innovation-office">Innovation Office</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/conducting">Conducting clinical trials</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/participating">Participating in clinical trials</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/regulatory-guidances">Guidance documents</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/clinical-trials-register">Clinical Trials Register</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/clinical-trials/statistics">Clinical trials statistics</a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/prism/clinical-trials">PRISM (Clinical trials) </a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/infosearch">Infosearch</a> </p> </li> </ul> </div> </div> </div> </section> </main> <div > <div ><div class="hsa-pre-footer"><div class="container p-y:s tab(p-y:s)"><div class="g:12 d:f fld:r ai:c"><div class="gcol:12 d:n tab(d:f) fld:r flw:w jc:c ai:c"> </div></div></div></div></div> </div> <div > <div ><footer role="contentinfo" class="bgc:grey-1 z:1"><div class="container p-y:l tab(p-y:xl)"><div><span class="d:b m-b:l c:grey-4 fw:bold">Health Sciences Authority</span> <div class="d:f fld:r flw:w jc:fs tab(jc:fe) fz:s m-b:l"><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/about-us">Who we are</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/announcements">Announcements</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/careers">Careers</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/contact-us">Contact us</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/feedback">Feedback</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="m-r:m fz:l hsa-glyphs--social-twitter-account" href="https://twitter.com/HSAsg" target="_blank" rel="noopener"></a><a class="m-r:m fz:l hsa-glyphs--social-youtube" href="https://www.youtube.com/user/HSAsingapore" target="_blank" rel="noopener"></a><a class="fz:l hsa-glyphs--social-linkedin" href="https://sg.linkedin.com/company/health-sciences-authority" target="_blank" rel="noopener"></a></div></div></div><hr class="d:n tab(d:b) type--2 height--1px m-y:xl" /><div class="g:12 d:f fld:r flw:w ai:fs jc:sb"><div class="gcol:12 tab(gcol:6)"><div class="d:f fld:r flw:w fz:s"><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="https://www.tech.gov.sg/report_vulnerability" target="_blank" rel="noopener">Report Vulnerability</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/privacy-statement">Privacy Statement</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/terms-of-use">Terms of Use</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/sitemap">Sitemap</a></div></div><div class="d:f fld:r flw:w fz:s m-b:m"><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="/hsa-data-protection-policy">HSA Data Protection Policy</a></div><div class="d:b dsk(d:ib) m-r:m w:100 tab(w:a)"><a class="type--footer" href="https://www.reach.gov.sg/" target="_blank" rel="noopener">Share your views @ REACH</a></div></div></div><div class="gcol:12 tab(gcol:5)"><p class="m-t:0 m-b:0 fz:s lh:s c:grey-4 ta:l tab(ta:r)">© <span class="copyrightYear">2019</span> Government of Singapore</p><p class="m-t:0 m-b:0 fz:s lh:s c:grey-4 ta:l tab(ta:r)">Last Updated <span id="pageUpdated">03 Sep 2019</span></p></div></div></div></footer></div> </div> <script type="text/javascript"> var title = document.title; var header = title.substring(0, 6); if (title == "Health Sciences Authority (HSA)") { title = "Home"; } else if (header == "HSA | ") { title = title.substring(6); } $(document).ready(function(){ if(document.getElementById("pageUpdatedDate") === null) { $.getJSON('/GetPageModified/'+title, function(x){ document.getElementById("pageUpdated").textContent = x.DateTimeStr; document.querySelector("footer #pageUpdated").textContent = x.DateTimeStr; }); } else{ document.getElementById("pageUpdated").textContent = document.getElementById("pageUpdatedDate").textContent; } }); </script> <script src="/Frontend-Assembly/Telerik.Sitefinity.Frontend/Mvc/Scripts/Home/PageUpdated.js?v=MjM5MjE2ODEx" type="text/javascript"></script> <script type="text/javascript" src="/_assets/scripts/bundle.min.js"></script> <script type="text/javascript"> //<![CDATA[ window.__TsmHiddenField = $get('ctl04_TSM');;(function() { function loadHandler() { var hf = $get('ctl05_TSSM'); if (!hf._RSSM_init) { hf._RSSM_init = true; hf.value = ''; } hf.value += ';Telerik.Sitefinity.Resources, Version=14.4.8140.0, Culture=neutral, PublicKeyToken=b28c218413bdf563:en:4f102d98-8cc9-4b2a-bf0d-b66909440278:7a90d6a'; Sys.Application.remove_load(loadHandler); }; Sys.Application.add_load(loadHandler); })();//]]> </script> </form></body> </html>

CINXE.COM

HSA | ​Template forms

HSA | Template forms