HSA | Adverse events reporting in clinical trials

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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 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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>Adverse events reporting in clinical trials</h1> <p class="hsa-text--summary">Understand the requirements for safety reporting in clinical trials.</p> </div> <div id="main_TB6F372E3007_Col01" class="sf_colsIn" data-sf-element="content" data-placeholder-label="content"><div id="main_C002_Col00" class="sf_colsIn hsa-card hsa-tab-toggle" data-sf-element="Tab Toggle" data-placeholder-label="Tab Toggle"><div id="main_C003_Col00" class="sf_colsIn tabpanel" data-sf-element="Tab Panel" data-placeholder-label="Tab Panel"> <div > <div ><h1>TPs, CTGTPs and MPs</h1><p>As there is limited safety information available for new treatments, it is important for local sponsors to report new safety information in a timely manner to us.</p><h2>What to report</h2><p>Unexpected serious adverse drug reactions (USADRs) should be reported to us in an expedited manner.</p><p>USADR refers to a serious adverse reaction arising from a therapeutic product (TP), cell, tissue or gene therapy product (CTGTP) or medicinal product (MP), in which its nature and severity is not consistent with the applicable product reference. The product reference can be the local product information leaflet (for products approved for marketing) or the Investigator's Brochure (for unregistered products).</p><p>Different reporting requirements apply, depending on the registration status of the product and how the product is used in the clinical trial: </p><table><tbody><tr><th>Registration status in Singapore</th><th>How the product is used in the clinical trial</th><th>Reporting requirements</th></tr><tr><td>Locally unregistered</td><td>Investigational product</td><td>Local and overseas USADRs should be reported </td></tr><tr><td>Locally unregistered</td><td>Auxiliary product</td><td>Local USADRs from the same clinical trial should be reported</td></tr><tr><td>Locally-registered</td><td>Investigational product</td><td><p>Local and overseas USADRs from the same clinical trial should be reported</p><p><strong>Note: </strong>For clinical trials not regulated by us, only local USADRs from the same clinical trial should be reported</p></td></tr><tr><td>Locally-registered</td><td>Comparator product</td><td>Local USADRs from the same clinical trial should be reported</td></tr><tr><td>Locally-registered</td><td>Auxiliary product</td><td>Local USADRs from the same clinical trial should be reported</td></tr></tbody></table><h2>When to report </h2><p>All USADRs should be submitted within a prescribed time from the local sponsor’s date of awareness.<br /><br />For fatal or life-threatening USADRs, local sponsors must submit the initial report as soon as possible and no later than 7 calendar days, with the next follow-up report within 8 calendar days of the initial report. Subsequent follow-up reports should be submitted in a timely manner as they become available.<br /><br />For other USADRs, local sponsors must submit the initial report as soon as possible and no later than 15 calendar days. Subsequent follow-up reports are to be submitted in a timely manner as they become available. </p><h3>Minimum criteria for reporting </h3><p>Initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: </p><ul><li>An identifiable patient</li><li>A suspect therapeutic or medicinal product</li><li>An identifiable reporting source</li><li>Event or outcome that can be identified as serious and unexpected</li><li>A reasonable suspected causal relationship</li></ul><h2>When to start and stop submitting safety reports</h2><p>Submission of USADRs should start immediately upon clinical trial authorisation, acceptance of notification or issuance of a clinical trial certificate.</p><p>However, should any new safety concerns surface from individual reports or aggregate analysis of USADR during the clinical trial application review period, local sponsors should ensure that the new safety information is promptly communicated to us via email, so that the information can be considered in the benefit-risk assessment of the clinical trial.</p><p>Submission of USADRs may stop when the Last Patient Last Visit (LPLV) is achieved in Singapore, unless otherwise indicated in the protocol. However, local sponsor should inform us of any new safety information that emerges thereafter, particularly if the information is of relevance or potential significance to previously-treated trial participants. </p><h2>How to report</h2><p>You may report the USADR to us using CIOMS-I form (<a title="Guidance on Expedited Safety Reporting Requirements for Clinical Trials" href="/docs/default-source/hprg-io-ctb/hsa_gn-ioctb-10_safety_reporting.pdf?sfvrsn=6687bb4f_6">view sample form in our guidance<em class="hsa-glyphs--pdf"></em><span>538 KB</span></a>). </p><p>It is recommended that the description for the USADRs be reported using <a href="https://www.meddra.org/" target="_blank" data-sf-ec-immutable="">Medical Dictionary for Regulatory Activities (MedDRA)</a>.</p><p>For regulated clinical trials, the safety reports should be submitted through the Expedited Safety Reporting (ESR) online module in PRISM. Ensure you have the following credentials before you access the e-service:</p><ul><li><a target="_blank" href="/e-services/cris">CRIS</a> company account </li><li><a href="https://www.corppass.gov.sg/cpauth/login/homepage?TAM_OP=login" target="_blank" data-sf-ec-immutable="">Corppass</a> or <a target="_blank" href="/e-services/hsa-pin">HSA PIN</a> </li></ul><p>If you encounter technical issues, e-mail the <a href="mailto:helpdesk@hsahelp.gov.sg">HSA helpdesk</a> or call 6776 0168 (from 7.00 am to midnight daily).</p><p>For clinical trials not regulated by us, the safety reports should be submitted via <a href="mailto:HSA_CT_SAE@hsa.gov.sg">e-mail to us</a>.</p><p> </p><p>Refer to our <a title="Guidance on Expedited Safety Reporting Requirements for Clinical Trials" href="/docs/default-source/hprg-io-ctb/hsa_gn-ioctb-10_safety_reporting.pdf?sfvrsn=6687bb4f_6">Guidance on Expedited Safety Reporting Requirements for Clinical Trials<em class="hsa-glyphs--pdf"></em><span>538 KB</span></a> for full details on our safety reporting requirements. </p></div> </div> </div><div id="main_C004_Col00" class="sf_colsIn tabpanel" data-sf-element="Tab Panel" data-placeholder-label="Tab Panel"> <div > <div ><h1>Medical devices</h1> <br /> <p>To achieve the objective of protecting health and safety of patients, users and others in clinical trials, safety issues associated with medical devices should be identified as soon as possible. </p> <p> These issues can then be addressed through modifications of medical device or clinical trial protocol, revision of the instructions for use, or withdrawal of the device from use.</p> <p> Refer to <a target="_blank" href="/medical-devices/guidance-documents#toggle=togglepanel-safety-monitoring">GN-05: Guidance on Reporting of Adverse Events for Medical Devices</a> for full details on adverse events reporting requirements.</p> <h2> What to report </h2> <p> As a general principle, you should be pre-disposed to report a medical device adverse event (AE). Any AE that meets the criteria listed below is considered reportable: </p> <ol> <li>An AE (or potential AE) has occurred. </li> <li>The device product is associated with the AE. </li> <li>The AE led to one of the following outcomes: <ul> <li>A serious threat to public health. </li> <li>Serious deterioration in state of health of patient, user or other person. </li> <li>No death or serious injury occurred but the event might lead to death or serious injury of a patient, user or other person if the event recurs. </li> <li>Death of a patient, user or other person. </li> </ul> </li> </ol> <h2> When to report </h2> <p> The following AEs must be reported to us within the indicated timelines: </p> <table> <thead> <tr> <th> Types of AEs </th> <th> Report within </th> </tr> </thead> <tbody> <tr> <td> Serious threat to public health </td> <td> 48 hours </td> </tr> <tr> <td> Results in death or serious deterioration in the state of health, of a patient, a user of the medical device or any other person </td> <td> 10 days<br /> <br /> </td> </tr> <tr> <td> May result in death or serious deterioration in the state of health, of a patient, a user of the medical device or any other person, if the AE were to recur </td> <td> 30 days </td> </tr> </tbody> </table> <p>The reporter should include as much relevant detail in the initial report as is immediately available, and should not delay the report for the sake of gathering additional information. </p> <p> The sponsor of the medical device clinical trial should follow up with a final report within 30 days of the initial report, detailing the investigation into the AE. Follow up reports may be requested as and when necessary. </p> <h2> How to report </h2> <p> It is mandatory for local sponsors and medical device companies (including product registrants, manufacturers, importers and suppliers) to report any AEs related to the medical devices they deal in.</p> <p> Please complete the <a title="Medical Device Adverse Event Report Form for Clinical Trials" href="/docs/default-source/hprg-io-ctb/hsa-ctb_medical-device-ae-report-form-(for-clinical-trials)_1aug2017.docx?sfvrsn=638e1df8_2">Medical Device Adverse Event Report Form for Clinical Trials<em class="hsa-glyphs--doc"></em><span>174 KB</span></a> and submit to us via <a href="mailto:HSA_CT_SAE@hsa.gov.sg">e-mail</a> with the subject as "Medical Device AE Reporting for Clinical Trials". </p></div> </div> </div> </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" 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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"> Report adverse events </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 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HSA | Adverse events reporting in clinical trials