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<span>Australia</span> </div> </a> <ul id="toc-Australia-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Brazil" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Brazil"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.2</span> <span>Brazil</span> </div> </a> <ul id="toc-Brazil-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Canada" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Canada"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.3</span> <span>Canada</span> </div> </a> <ul id="toc-Canada-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-China" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#China"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.4</span> <span>China</span> </div> </a> <ul id="toc-China-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Egypt" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Egypt"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.5</span> <span>Egypt</span> </div> </a> <ul id="toc-Egypt-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-European_Union" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#European_Union"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.6</span> <span>European Union</span> </div> </a> <ul id="toc-European_Union-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Germany" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Germany"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.7</span> <span>Germany</span> </div> </a> <ul id="toc-Germany-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Iceland" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Iceland"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.8</span> <span>Iceland</span> </div> </a> <ul id="toc-Iceland-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-India" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#India"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.9</span> <span>India</span> </div> </a> <ul id="toc-India-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Indonesia" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Indonesia"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.10</span> <span>Indonesia</span> </div> </a> <ul id="toc-Indonesia-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Ireland" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Ireland"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.11</span> <span>Ireland</span> </div> </a> <ul id="toc-Ireland-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Myanmar_(Burma)" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Myanmar_(Burma)"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.12</span> <span>Myanmar (Burma)</span> </div> </a> <ul id="toc-Myanmar_(Burma)-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Norway" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Norway"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.13</span> <span>Norway</span> </div> </a> <ul id="toc-Norway-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Philippines" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Philippines"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.14</span> <span>Philippines</span> </div> </a> <ul id="toc-Philippines-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Sri_Lanka" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Sri_Lanka"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.15</span> <span>Sri Lanka</span> </div> </a> <ul id="toc-Sri_Lanka-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Switzerland" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Switzerland"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.16</span> <span>Switzerland</span> </div> </a> <ul id="toc-Switzerland-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-United_Kingdom_2" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#United_Kingdom_2"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.17</span> <span>United Kingdom</span> </div> </a> <ul id="toc-United_Kingdom_2-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-United_States_2" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#United_States_2"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.18</span> <span>United States</span> </div> </a> <ul id="toc-United_States_2-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-See_also" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#See_also"> <div class="vector-toc-text"> <span class="vector-toc-numb">3</span> <span>See also</span> </div> </a> <ul id="toc-See_also-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-References" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#References"> <div class="vector-toc-text"> <span class="vector-toc-numb">4</span> <span>References</span> </div> </a> <ul id="toc-References-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-External_links" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#External_links"> <div class="vector-toc-text"> <span class="vector-toc-numb">5</span> <span>External links</span> </div> </a> <ul id="toc-External_links-sublist" class="vector-toc-list"> </ul> </li> </ul> </div> </div> </nav> </div> </div> <div class="mw-content-container"> <main id="content" class="mw-body"> <header class="mw-body-header vector-page-titlebar"> <nav aria-label="Contents" class="vector-toc-landmark"> <div id="vector-page-titlebar-toc" class="vector-dropdown vector-page-titlebar-toc vector-button-flush-left" > <input type="checkbox" id="vector-page-titlebar-toc-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-page-titlebar-toc" class="vector-dropdown-checkbox " aria-label="Toggle the table of contents" > <label id="vector-page-titlebar-toc-label" for="vector-page-titlebar-toc-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-listBullet mw-ui-icon-wikimedia-listBullet"></span> <span class="vector-dropdown-label-text">Toggle the table of contents</span> </label> <div class="vector-dropdown-content"> <div id="vector-page-titlebar-toc-unpinned-container" class="vector-unpinned-container"> </div> </div> </div> </nav> <h1 id="firstHeading" class="firstHeading mw-first-heading"><span class="mw-page-title-main">Regulation of therapeutic goods</span></h1> <div id="p-lang-btn" class="vector-dropdown mw-portlet mw-portlet-lang" > <input type="checkbox" id="p-lang-btn-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-p-lang-btn" class="vector-dropdown-checkbox mw-interlanguage-selector" aria-label="Go to an article in another language. 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class="interlanguage-link-target"><span>العربية</span></a></li><li class="interlanguage-link interwiki-ca mw-list-item"><a href="https://ca.wikipedia.org/wiki/R%C3%A8gim_de_dispensaci%C3%B3_d%27un_producte_farmac%C3%A8utic" title="Règim de dispensació d'un producte farmacèutic – Catalan" lang="ca" hreflang="ca" data-title="Règim de dispensació d'un producte farmacèutic" data-language-autonym="Català" data-language-local-name="Catalan" class="interlanguage-link-target"><span>Català</span></a></li><li class="interlanguage-link interwiki-fa mw-list-item"><a href="https://fa.wikipedia.org/wiki/%D8%A2%DB%8C%DB%8C%D9%86%E2%80%8C%D9%86%D8%A7%D9%85%D9%87_%DA%A9%D8%A7%D9%84%D8%A7%D9%87%D8%A7%DB%8C_%D8%AF%D8%B1%D9%85%D8%A7%D9%86%DB%8C" title="آیین‌نامه کالاهای درمانی – Persian" lang="fa" hreflang="fa" data-title="آیین‌نامه کالاهای درمانی" data-language-autonym="فارسی" data-language-local-name="Persian" class="interlanguage-link-target"><span>فارسی</span></a></li><li class="interlanguage-link interwiki-id mw-list-item"><a href="https://id.wikipedia.org/wiki/Regulasi_perbekalan_kesehatan" title="Regulasi perbekalan kesehatan – Indonesian" lang="id" hreflang="id" data-title="Regulasi perbekalan kesehatan" data-language-autonym="Bahasa Indonesia" data-language-local-name="Indonesian" class="interlanguage-link-target"><span>Bahasa Indonesia</span></a></li><li class="interlanguage-link interwiki-ms mw-list-item"><a href="https://ms.wikipedia.org/wiki/Pengawalan_barang_terapeutik" title="Pengawalan barang terapeutik – Malay" lang="ms" hreflang="ms" data-title="Pengawalan barang terapeutik" data-language-autonym="Bahasa Melayu" data-language-local-name="Malay" class="interlanguage-link-target"><span>Bahasa Melayu</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/%E5%8C%BB%E7%99%82%E5%93%81%E8%A6%8F%E5%88%B6" title="医療品規制 – Japanese" lang="ja" hreflang="ja" data-title="医療品規制" data-language-autonym="日本語" data-language-local-name="Japanese" class="interlanguage-link-target"><span>日本語</span></a></li><li class="interlanguage-link interwiki-sco mw-list-item"><a href="https://sco.wikipedia.org/wiki/Regulation_o_therapeutic_guids" title="Regulation o therapeutic guids – Scots" lang="sco" hreflang="sco" data-title="Regulation o therapeutic guids" data-language-autonym="Scots" data-language-local-name="Scots" class="interlanguage-link-target"><span>Scots</span></a></li><li class="interlanguage-link interwiki-sr mw-list-item"><a href="https://sr.wikipedia.org/wiki/Regulacija_terapeutskih_dobara" title="Regulacija terapeutskih dobara – Serbian" lang="sr" hreflang="sr" data-title="Regulacija terapeutskih dobara" data-language-autonym="Српски / srpski" data-language-local-name="Serbian" class="interlanguage-link-target"><span>Српски / srpski</span></a></li><li class="interlanguage-link interwiki-sh mw-list-item"><a href="https://sh.wikipedia.org/wiki/Regulacija_terapeutskih_dobara" title="Regulacija terapeutskih dobara – Serbo-Croatian" lang="sh" hreflang="sh" data-title="Regulacija terapeutskih dobara" data-language-autonym="Srpskohrvatski / српскохрватски" data-language-local-name="Serbo-Croatian" class="interlanguage-link-target"><span>Srpskohrvatski / српскохрватски</span></a></li><li class="interlanguage-link interwiki-fi mw-list-item"><a href="https://fi.wikipedia.org/wiki/L%C3%A4%C3%A4kevalmisteiden_s%C3%A4%C3%A4ntely" title="Lääkevalmisteiden sääntely – Finnish" lang="fi" hreflang="fi" data-title="Lääkevalmisteiden sääntely" data-language-autonym="Suomi" data-language-local-name="Finnish" class="interlanguage-link-target"><span>Suomi</span></a></li><li class="interlanguage-link interwiki-tl mw-list-item"><a href="https://tl.wikipedia.org/wiki/Regulasyon_ng_gamot" title="Regulasyon ng gamot – Tagalog" lang="tl" hreflang="tl" data-title="Regulasyon ng gamot" data-language-autonym="Tagalog" data-language-local-name="Tagalog" class="interlanguage-link-target"><span>Tagalog</span></a></li><li class="interlanguage-link interwiki-tr mw-list-item"><a href="https://tr.wikipedia.org/wiki/Tedavi_maddelerinin_yasal_d%C3%BCzenlemesi" title="Tedavi maddelerinin yasal düzenlemesi – Turkish" lang="tr" hreflang="tr" data-title="Tedavi maddelerinin yasal düzenlemesi" data-language-autonym="Türkçe" data-language-local-name="Turkish" class="interlanguage-link-target"><span>Türkçe</span></a></li><li class="interlanguage-link interwiki-zh mw-list-item"><a href="https://zh.wikipedia.org/wiki/%E9%86%AB%E7%99%82%E7%94%A2%E5%93%81%E6%B3%95%E5%BE%8B%E8%A6%8F%E7%AF%84" title="醫療產品法律規範 – Chinese" lang="zh" hreflang="zh" data-title="醫療產品法律規範" data-language-autonym="中文" data-language-local-name="Chinese" class="interlanguage-link-target"><span>中文</span></a></li> </ul> <div class="after-portlet after-portlet-lang"><span class="wb-langlinks-edit wb-langlinks-link"><a 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data-mw-ve-target-container> <div class="vector-body-before-content"> <div class="mw-indicators"> </div> <div id="siteSub" class="noprint">From Wikipedia, the free encyclopedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Legal management of drugs and restricted substances</div> <style data-mw-deduplicate="TemplateStyles:r1236090951">.mw-parser-output .hatnote{font-style:italic}.mw-parser-output div.hatnote{padding-left:1.6em;margin-bottom:0.5em}.mw-parser-output .hatnote i{font-style:normal}.mw-parser-output .hatnote+link+.hatnote{margin-top:-0.5em}@media print{body.ns-0 .mw-parser-output .hatnote{display:none!important}}</style><div role="note" class="hatnote navigation-not-searchable">For laws prohibiting other drugs, see <a href="/wiki/Prohibition_of_drugs" class="mw-redirect" title="Prohibition of drugs">Prohibition of drugs</a>.</div> <figure class="mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:Ritalin-SR-20mg-1000x1000.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/a/a9/Ritalin-SR-20mg-1000x1000.jpg/200px-Ritalin-SR-20mg-1000x1000.jpg" decoding="async" width="200" height="200" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/a/a9/Ritalin-SR-20mg-1000x1000.jpg/300px-Ritalin-SR-20mg-1000x1000.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/a/a9/Ritalin-SR-20mg-1000x1000.jpg/400px-Ritalin-SR-20mg-1000x1000.jpg 2x" data-file-width="1168" data-file-height="1168" /></a><figcaption><a href="/wiki/Methylphenidate" title="Methylphenidate">Methylphenidate</a>, in the form of Ritalin pills</figcaption></figure> <p>The regulation of <b>therapeutic goods</b>, defined as <b>drugs</b> and <b>therapeutic devices</b>, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the <a href="/wiki/State_(administrative_division)" class="mw-redirect" title="State (administrative division)">state</a> level, or at both state and national levels by various bodies, as in Australia. </p><p>The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold. There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers. </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=1" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of <a href="/wiki/Mithridates_VI_of_Pontus" class="mw-redirect" title="Mithridates VI of Pontus">Mithridates</a>' death.<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> Mithridates had brought together physicians, scientists, and shamans to concoct a potion that would make him immune to poisons. Following his death, the Romans became keen on further developing the Mithridates potion's recipe. Mithridatium re-entered western society through multiple means. The first was through the <i>Leechbook of the Bald</i> (<i><a href="/wiki/Bald%27s_Leechbook" title="Bald's Leechbook">Bald's Leechbook</a></i>), written somewhere between 900 and 950, which contained a formula for various remedies, including for a theriac. Additionally, theriac became a commercial good traded throughout Europe based on the works of Greek and Roman physicians.<sup id="cite_ref-:0_2-0" class="reference"><a href="#cite_note-:0-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p><p>The resulting proliferation of various recipes needed to be curtailed in order to ensure that people were not passing off fake antidotes, which led to the development of government involvement and regulation. Additionally, the creation of these concoctions took on ritualistic form and were often created in public and the process was observed and recorded. It was believed that if the concoction proved unsuccessful, it was due to the apothecaries' process of making them and they could be held accountable because of the public nature of the creation.<sup id="cite_ref-:0_2-1" class="reference"><a href="#cite_note-:0-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p><p>In the ninth century, many Muslim countries established an office of the <i><a href="/wiki/Hisbah" class="mw-redirect" title="Hisbah">hisba</a></i>, which in addition to regulating compliance to Islamic principles and values took on the role of regulating other aspects of social and economic life, including the regulation of medicines. Inspectors were appointed to employ oversight on those who were involved in the process of medicine creation and were given a lot of leeway to ensure compliance and punishments were stringent.<sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> The first official 'act', the 'Apothecary Wares, Drugs and Stuffs' Act (also sometimes referred to as the 'Pharmacy Wares, Drugs and Stuffs' Act) was passed in 1540 by Henry VIII and set the foundation for others. Through this act, he encouraged physicians in his <i>College of Physicians</i> (founded by him in 1518) to appoint four people dedicated to consistently inspecting what was being sold in apothecary shops.<sup id="cite_ref-:0_2-2" class="reference"><a href="#cite_note-:0-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> In conjunction with this first piece of legislation, there was an emergence of standard formulas for the creation of certain 'drugs' and 'antidotes' through <a href="/wiki/Pharmacopoeia" title="Pharmacopoeia">Pharmacopoeias</a> which first appeared in the form of a decree from <a href="/wiki/Frederick_II,_Holy_Roman_Emperor" title="Frederick II, Holy Roman Emperor">Frederick II of Sicily</a> in 1240 to use consistent and standard formulas.<sup id="cite_ref-:1_4-0" class="reference"><a href="#cite_note-:1-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> The first modern pharmacopoeias were the Florence Pharmacopoeia published in 1498,<sup id="cite_ref-:0_2-3" class="reference"><a href="#cite_note-:0-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> the Spanish Pharmacopoeia published in 1581 and the London Pharmacopoeia published in 1618.<sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> </p><p>Various other events throughout history have demonstrated the importance of drug and medicine regulation keeping up with scientific advances. In 2006, the challenges associated with <a href="/wiki/TGN1412" class="mw-redirect" title="TGN1412">TGN 1412</a> highlighted the shortcomings of animal models and paved the way for further advances in regulation and development for biological products. <a href="/wiki/Rofecoxib" title="Rofecoxib">Rofecoxib</a> represents a drug that was on the market that had not clearly represent the risks associated with the use drug which led to the concept of 'risk management planning' within the field of regulation by introducing the need to understand how various safety concerns would be managed. Various cases over recent years have demonstrated the need for regulation to keep up with scientific advances that have implications for people's health.<sup id="cite_ref-:3_6-0" class="reference"><a href="#cite_note-:3-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="United_States">United States</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=2" title="Edit section: United States"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, the need for stronger federal regulation increased.<sup id="cite_ref-:2_7-0" class="reference"><a href="#cite_note-:2-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> In 1906 President Roosevelt signed the Federal Food and Drug Act (FFDA) which both established stricter national standards for drug manufacture and sales, and also established the Federal government as the regulating authority over the US drug industry.<sup id="cite_ref-:2_7-1" class="reference"><a href="#cite_note-:2-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> A 1911 Supreme Court decision, <i>United States vs. Johnson</i>, established that misleading statements were not covered under the FFDA. This directly led to Congress passing the Sherley Amendment which established a clearer definition of 'drug marketing requirements'.<sup id="cite_ref-:2_7-2" class="reference"><a href="#cite_note-:2-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> </p><p>More catalysts for advances in drug regulation in the US were certain catastrophes that served as calls to the US government to step in and impose regulations that would prevent repeats of those instances. One such instance occurred in 1937 when more than a hundred people died from using sulfanilamide elixir which had not gone through any safety testing.<sup id="cite_ref-:2_7-3" class="reference"><a href="#cite_note-:2-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-:1_4-1" class="reference"><a href="#cite_note-:1-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> This directly led to the passing of the <a href="/wiki/Federal_Food,_Drug,_and_Cosmetic_Act" class="mw-redirect" title="Federal Food, Drug, and Cosmetic Act">Federal, Food, Drug, and Cosmetic Act</a> in 1938. One other major catastrophe occurred in the late 1950s when Thalidomide, which was originally sold in Germany (introduced into a virtually unregulated market) and eventually sold around the world, led to approximately 100,000 babies being born with various deformities.<sup id="cite_ref-:1_4-2" class="reference"><a href="#cite_note-:1-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> In 1962 the United States Congress passed the <a href="/wiki/Drug_Efficacy_Amendment" class="mw-redirect" title="Drug Efficacy Amendment">Drug Amendments Act of 1962</a>. The Drug Amendments Act required the FDA to ensure that new drugs being introduced to the market had passed certain tests and standards.<sup id="cite_ref-:2_7-4" class="reference"><a href="#cite_note-:2-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="United_Kingdom">United Kingdom</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=3" title="Edit section: United Kingdom"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The UK's Chief Medical Officer had established a group to look into safety of drugs on the market in 1959 prior to the crisis and was moving in the direction of address the problem of unregulated drugs entering the market. The crisis created a greater sense of emergency to establish safety and efficacy standards around the world. The UK started a temporary Committee on Safety of Drugs while they attempted to pass more comprehensive legislation. Though compliance and submission of drugs to the Committee on Safety of Drugs was not mandatory immediately after, the pharmaceutical industry later complied due to the thalidomide situation.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="European_Economic_Union">European Economic Union</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=4" title="Edit section: European Economic Union"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The European Economic Commission also passed a directive in 1965 in order to impose greater efficacy standards before marketing a drug.<sup id="cite_ref-:3_6-1" class="reference"><a href="#cite_note-:3-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> Drug legislation in both the EU and US were passed in order to assure drug safety and efficacy. Of note, increased regulations and standards for testing actually led to greater innovation in pharmaceutical research in the 1960s, despite greater preclinical and clinical standards.<sup id="cite_ref-:3_6-2" class="reference"><a href="#cite_note-:3-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> In 1989, the International Conference of Drug Regulatory Authorities organized by the WHO, officials from around the world discussed the necessity for streamlined processes for global drug approval.<sup id="cite_ref-:1_4-3" class="reference"><a href="#cite_note-:1-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Regulatory_authorities_and_key_legislation_by_country">Regulatory authorities and key legislation by country</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=5" title="Edit section: Regulatory authorities and key legislation by country"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/List_of_stringent_regulatory_authorities" title="List of stringent regulatory authorities">List of stringent regulatory authorities</a></div> <div class="mw-heading mw-heading3"><h3 id="Australia">Australia</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=6" title="Edit section: Australia"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Therapeutic goods in Australia are regulated by the <a href="/wiki/Therapeutic_Goods_Administration" title="Therapeutic Goods Administration">Therapeutic Goods Administration</a> (TGA), which is a regulatory body of the Commonwealth Department of Health.<sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> Access to medicines and poisons is regulated by the separation of substances into various schedules according to the Therapeutic Goods (Poisons Standard) Instrument, the Poisons Standard may also be cited as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).<sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> </p><p>The Poisons Standard organises substances into 10 schedules (and unscheduled substances),<sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup> therapeutic goods are generally organised only into schedules 2, 3, 4 and 8: </p> <ul><li>unscheduled substances: unscheduled substances are available for purchase at any retailer.</li> <li>schedule 1 (S1) - Blank: this schedule is left intentionally blank.</li> <li>schedule 2 (S2) - Pharmacy medicines: substances in schedule 2 are only available for purchase in a pharmacy or other licensed retailer.</li> <li>schedule 3 (S3) - Pharmacist only medicines: substances in schedule 3 are only available for purchase in a pharmacy and a pharmacist must be involved in the sale of the medicine.</li> <li>schedule 4 (S4) - Prescription only medicines and prescription animal remedies: substances in schedule 4 are only available with a prescription from a prescriber (medical practitioners, dentists, nurse practitioners, endorsed physiotherapists and podiatrists) and must be purchased at a pharmacy.</li> <li>schedule 5 (S5) - Caution</li> <li>schedule 6 (S6) - Poisons</li> <li>schedule 7 (S7) - Dangerous Poisons</li> <li>schedule 8 (S8) - Controlled drugs: substances in schedule 8 are generally drugs of addiction or dependence and are only available with a prescription from an authorised prescriber, they must be purchased at a pharmacy. Schedule 8 medicines have additional controls on their storage, supply, possession, destruction and prescription compared to schedule 4 substances.</li> <li>schedule 9 (S9) - Prohibited substances</li> <li>schedule 10 (S10) - Substances of such danger to health as to warrant prohibition of supply and use</li></ul> <div class="mw-heading mw-heading3"><h3 id="Brazil">Brazil</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=7" title="Edit section: Brazil"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Brazilian_Controlled_Drugs_and_Substances_Act" title="Brazilian Controlled Drugs and Substances Act">Brazilian Controlled Drugs and Substances Act</a></div> <p>Therapeutic goods in Brazil are regulated by the <a href="/wiki/Ministry_of_Health_(Brazil)" title="Ministry of Health (Brazil)">Ministry of Health of Brazil</a>, through its <a href="/wiki/Brazilian_Health_Regulatory_Agency" title="Brazilian Health Regulatory Agency">Brazilian Health Regulatory Agency</a> (Anvisa), equivalent to the US <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a>. There are six main categories:<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p> <ul><li><a href="/wiki/Over-the-counter_drug" title="Over-the-counter drug">Over-the-counter</a> (OTC) medicines (<i>medicamentos isentos de prescrição</i> or <i>MIPs</i> in <a href="/wiki/Portuguese_language" title="Portuguese language">Portuguese</a>): cough, cold and fever medicines, <a href="/wiki/Antiseptic" title="Antiseptic">antiseptics</a>, <a href="/wiki/Vitamin" title="Vitamin">vitamins</a> and others. Sold freely in pharmacies.</li> <li>Red stripe medicines: sold only with medical prescription. Anti-allergenics, <a href="/wiki/Anti-inflammatory" title="Anti-inflammatory">anti-inflammatories</a>, and other medicines.</li> <li>Red stripe antibiotics: <a href="/wiki/Antibiotics" class="mw-redirect" title="Antibiotics">antibiotics</a> are sold only with a "special control" white medical prescription with patient's copy, which is valid for 10 days. The original must be retained by the pharmacist after the sale and the patient keeps the copy.</li> <li>Red stripe psychoactive medicines: sold only with a "special control" white medical prescription with patient's copy, which is valid for 30 days. The original must be retained by the pharmacist after the sale and the patient keeps the copy. Drugs include <a href="/wiki/Anti-depressant" class="mw-redirect" title="Anti-depressant">anti-depressants</a>, <a href="/wiki/Anti-convulsant" class="mw-redirect" title="Anti-convulsant">anti-convulsants</a>, some sleep aids, anti-psychotics and other non-habit-inducing controlled medicines. Though some consider them habit inducing, anabolic steroids are also regulated under this category.</li> <li>Black stripe medicines: sold only with the "blue B form" medical prescription, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes <a href="/wiki/Sedatives" class="mw-redirect" title="Sedatives">sedatives</a> (<a href="/wiki/Benzodiazepines" class="mw-redirect" title="Benzodiazepines">benzodiazepines</a>), some anorexic inducers and other habit-inducing controlled medicines.</li> <li>"Yellow A form" prescription medicines: sold only with the "yellow A form" medical prescription - the most tightly controlled, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes amphetamines and other stimulants (such as <a href="/wiki/Methylphenidate" title="Methylphenidate">methylphenidate</a>), <a href="/wiki/Opioids" class="mw-redirect" title="Opioids">opioids</a> (such as <a href="/wiki/Morphine" title="Morphine">morphine</a> and oxycodone) and other strong habit-forming controlled medicines.<sup id="cite_ref-11" class="reference"><a href="#cite_note-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup></li></ul> <p><a href="/wiki/Biopharmaceutical" title="Biopharmaceutical">Biological medications</a> are complex molecules of high molecular weight obtained from a biological source or biotechnological procedures and are divided by Anvisa into the following categories:<sup id="cite_ref-12" class="reference"><a href="#cite_note-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <ul><li>Allergens: substances from animals or plants that can induce an IgE response or a type I <a href="/wiki/Hypersensitivity" title="Hypersensitivity">hypersensitivity</a> reaction</li> <li>Monoclonal antibodies: immunoglobulins derived from the same B lymphocyte clone, propagated in continuous cell lines</li> <li>Biomedicines: obtained from biological fluids or tissues of animal origin or through biotechnological procedures</li> <li>Blood derivatives: obtained from human plasma, subjected to industrialization and standardization processes</li> <li>Probiotics: preparations containing viable microorganisms in sufficient quantity to change the <a href="/wiki/Microbiota" title="Microbiota">microbiota</a></li> <li>Vaccines: immunobiological medications<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-14" class="reference"><a href="#cite_note-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> that contain one or more antigenic substances capable of inducing immunity to protect against disease, reduce its severity or fight it</li></ul> <p>The regulatory status of vaccines, which determines their marketing and distribution, may be one of the following established by Anvisa:<sup id="cite_ref-15" class="reference"><a href="#cite_note-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> </p> <ul><li>Sanitary vaccine registration: definitive, for <a href="/wiki/Approved_drug" title="Approved drug">approved drugs</a></li> <li>Temporary emergency use authorization: similar to a US <a href="/wiki/Emergency_Use_Authorization" title="Emergency Use Authorization">Emergency Use Authorization</a></li> <li>Exceptional import authorization</li> <li>COVAX Facility: temporarily lifts the requirement of registration or emergency use authorization for vaccines purchased by the Ministry of Health that are under the <a href="/wiki/World_Health_Organization%27s_response_to_the_COVID-19_pandemic" class="mw-redirect" title="World Health Organization's response to the COVID-19 pandemic">Emergency Use Listing of the World Health Organization</a><sup id="cite_ref-16" class="reference"><a href="#cite_note-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup></li></ul> <p>Vaccines can only be administered in public <a href="/wiki/Community_health_center" title="Community health center">health centers</a> or authorized private vaccination services.<sup id="cite_ref-17" class="reference"><a href="#cite_note-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Canada">Canada</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=8" title="Edit section: Canada"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In Canada, regulation of therapeutic goods is done by <a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a> and governed by the <a href="/wiki/Food_and_Drug_Act" class="mw-redirect" title="Food and Drug Act">Food and Drug Act</a> and associated regulations. In addition, the <a href="/wiki/Controlled_Drugs_and_Substances_Act" title="Controlled Drugs and Substances Act">Controlled Drugs and Substances Act</a> specifies additional regulatory requirements for controlled drugs and drug precursors.<sup id="cite_ref-HealthCanadaFacts_18-0" class="reference"><a href="#cite_note-HealthCanadaFacts-18"><span class="cite-bracket">[</span>18<span class="cite-bracket">]</span></a></sup> </p><p>In <a href="/wiki/Ontario" title="Ontario">Ontario</a>, the <a href="/w/index.php?title=Drug_and_Pharmacies_Regulation_Act&action=edit&redlink=1" class="new" title="Drug and Pharmacies Regulation Act (page does not exist)">Drug and Pharmacies Regulation Act</a> governs "any substance that is used in the diagnosis, treatment, mitigation or prevention of a disease...in humans, animals or fowl."<sup id="cite_ref-ocps_19-0" class="reference"><a href="#cite_note-ocps-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="China">China</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=9" title="Edit section: China"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The regulation of drugs in China is governed by the <a rel="nofollow" class="external text" href="http://english.nmpa.gov.cn/">National Medical Products Administration (NMPA)</a> which replaced the former <a href="/wiki/China_Food_and_Drug_Administration" class="mw-redirect" title="China Food and Drug Administration">China Food and Drug Administration</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Egypt">Egypt</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=10" title="Edit section: Egypt"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The regulation of drugs in Egypt is governed by the <a rel="nofollow" class="external text" href="https://edaegypt.gov.eg/en/">Egyptian Drug Authority (EDA)</a> </p> <div class="mw-heading mw-heading3"><h3 id="European_Union">European Union</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=11" title="Edit section: European Union"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA). EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information. They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials, and the conduct of inspections of medicines' manufacturers and compliance with <a href="/wiki/Good_clinical_practice" title="Good clinical practice">good clinical practice</a> (GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP). EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines.<sup id="cite_ref-20" class="reference"><a href="#cite_note-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> </p><p>Within the EU, <a href="/wiki/EudraLex" title="EudraLex">EudraLex</a> maintains the collection of rules and regulations governing medicinal products in the European Union, and the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> acts to regulate many of these rules and regulations. Amongst these rules and regulations are: </p> <ul><li><a href="/wiki/Directive_65/65/EEC1" class="mw-redirect" title="Directive 65/65/EEC1">Directive 65/65/EEC1</a>, requires prior approval for marketing of proprietary medicinal products</li> <li><a href="/wiki/Directive_75/318/EEC" title="Directive 75/318/EEC">Directive 75/318/EEC</a>, clarifies requirements of 65/65/EEC1 and requires member states to enforce them</li> <li><a href="/wiki/Directive_75/319/EEC" title="Directive 75/319/EEC">Directive 75/319/EEC</a>, requires marketing authorization requests to be drawn up only by qualified experts</li> <li><a href="/wiki/Directive_93/41/EEC" title="Directive 93/41/EEC">Directive 93/41/EEC</a>, establishes the European Agency for the Evaluation of Medicinal Products</li> <li><a href="/wiki/Directive_2001/20/EC" class="mw-redirect" title="Directive 2001/20/EC">Directive 2001/20/EC</a>, defines rules for the conduct of <a href="/wiki/Clinical_trials" class="mw-redirect" title="Clinical trials">clinical trials</a></li> <li><a href="/wiki/Directive_2001/83/EC" title="Directive 2001/83/EC">Directive 2001/83/EC</a></li> <li><a href="/wiki/Directive_2005/28/EC" class="mw-redirect" title="Directive 2005/28/EC">Directive 2005/28/EC</a>, defines Good Clinical Practice for design and conduct of clinical trials</li></ul> <div class="mw-heading mw-heading3"><h3 id="Germany">Germany</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=12" title="Edit section: Germany"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/List_of_German_drug_laws" title="List of German drug laws">List of German drug laws</a></div> <p>German law classifies drugs into </p> <ul><li>Narcotics ("Betäubungsmittel") <ul><li><a href="/wiki/Anlage_I" class="mw-redirect" title="Anlage I">Anlage I</a> BTMG (authorized scientific use only)</li> <li><a href="/wiki/Anlage_II" class="mw-redirect" title="Anlage II">Anlage II</a> BTMG (authorized trade only, not prescriptible)</li> <li><a href="/wiki/Anlage_III" class="mw-redirect" title="Anlage III">Anlage III</a> BTMG (<a href="/wiki/Special_prescription_form" title="Special prescription form">special prescription form</a> required – "Betäubungsmittelrezept")</li></ul></li> <li><a href="/wiki/Research_chemical" title="Research chemical">Research chemicals</a> ("neue psychoaktive Stoffe" – permitted only for industrial and scientific purposes)</li> <li><a href="/wiki/Prescription_drug" title="Prescription drug">Prescription drugs</a> ("verschreibungspflichtig" or "rezeptpflichtig")</li> <li>Pharmacy-only drugs ("apothekenpflichtig")</li> <li>General sales list drugs ("freiverkäuflich")</li> <li><a href="/wiki/Raw_material" title="Raw material">Raw materials</a> for synthesizing drugs <ul><li>Kategorie 1 (authorization required)</li> <li>Kategorie 2 (reporting required)</li> <li>Kategorie 3 (export restrictions)</li></ul></li></ul> <div class="mw-heading mw-heading3"><h3 id="Iceland">Iceland</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=13" title="Edit section: Iceland"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Medicines in Iceland are regulated by the <a href="/w/index.php?title=Icelandic_Medicines_Control_Agency&action=edit&redlink=1" class="new" title="Icelandic Medicines Control Agency (page does not exist)">Icelandic Medicines Control Agency</a>.<sup id="cite_ref-21" class="reference"><a href="#cite_note-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="India">India</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=14" title="Edit section: India"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Drug_policy_of_India" title="Drug policy of India">Drug policy of India</a></div> <p>Medicines in India are regulated by <a href="/wiki/Central_Drugs_Standard_Control_Organization" class="mw-redirect" title="Central Drugs Standard Control Organization">Central Drugs Standard Control Organization</a> (CDSCO) Under <a href="/wiki/Ministry_of_Health_and_Family_Welfare" title="Ministry of Health and Family Welfare">Ministry of Health and Family Welfare</a>. Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through <a href="/wiki/Drugs_Controller_General_of_India" title="Drugs Controller General of India">Drugs Controller General of India</a> (DCGI) at chair.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p><p>Drugs are classified under five headings. Under retail and distribution:<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <ul><li>Schedule X drugs - narcotics</li> <li>Schedule H and L - injectables, antibiotics, antibacterials</li> <li>Schedule C and C1 - biological products, for example serums and vaccines</li></ul> <p>Under manufacturing practice: </p> <ul><li>Schedule N - list of the equipment for the efficient running of manufacturing wing, qualified personnel</li> <li>Schedule M</li></ul> <div class="mw-heading mw-heading3"><h3 id="Indonesia">Indonesia</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=15" title="Edit section: Indonesia"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Medicines in <a href="/wiki/Indonesia" title="Indonesia">Indonesia</a> are regulated by <a href="/wiki/National_Agency_of_Drug_and_Food_Control_of_Indonesia" class="mw-redirect" title="National Agency of Drug and Food Control of Indonesia">National Agency of Drug and Food Control of Indonesia</a>. Drugs in Indonesia are classified into:<sup id="cite_ref-22" class="reference"><a href="#cite_note-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-23" class="reference"><a href="#cite_note-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p> <ul><li>Over-the-counter (OTC) drug (<i>Obat bebas</i>), drugs freely available to the public. Marked by green circle with black line.</li> <li>Limited OTC drug (<i>Obat bebas terbatas</i>), drugs available to the public only through pharmacy (<i>apotek</i>) or licensed drug stores. Marked by blue circle with black line.</li> <li>Prescription drug (<i>Obat keras</i>), prescription only medicine. Marked by red circle with letter "K" inside circle and black line.</li> <li>Narcotics and psychoactive drugs (<i>Obat psikotropika dan narkotika</i>). <a href="/wiki/National_Narcotics_Board_(Indonesia)" class="mw-redirect" title="National Narcotics Board (Indonesia)">National Narcotics Board</a> perform law enforcement measure at illegal drug abuse and drug trafficking.</li></ul> <div class="mw-heading mw-heading3"><h3 id="Ireland">Ireland</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=16" title="Edit section: Ireland"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Medicines in Ireland are regulated according to the <a href="/wiki/Misuse_of_Drugs_Act_(Ireland)" class="mw-redirect" title="Misuse of Drugs Act (Ireland)">Misuse of Drugs Regulations 1988</a>. Controlled drugs (CDs) are divided into five categories based on their potential for misuse and therapeutic effectiveness.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p> <ul><li><b>CD1</b>: <a href="/wiki/Cannabis" title="Cannabis">cannabis</a>, <a href="/wiki/Lysergamide" class="mw-redirect" title="Lysergamide">lysergamide</a>, <a href="/wiki/Coca_leaf" class="mw-redirect" title="Coca leaf">coca leaf</a>, etc. Use is prohibited except in limited circumstances where a license has been granted.</li> <li><b>CD2</b>: <a href="/wiki/Amphetamine" title="Amphetamine">amphetamine</a>, <a href="/wiki/Methadone" title="Methadone">methadone</a>, <a href="/wiki/Morphine" title="Morphine">morphine</a>, <a href="/wiki/Fentanyl" title="Fentanyl">fentanyl</a>, <a href="/wiki/Oxycodone" title="Oxycodone">oxycodone</a>, <a href="/wiki/Tapentadol" title="Tapentadol">tapentadol</a>, etc. Prescriptions must be handwritten and are only valid for 14 days. Repeat prescriptions are not permitted. Drugs must comply with safe custody and destruction of unsold/unused medication must be witnessed. Must be registered in a Controlled Drugs register.</li> <li><b>CD3</b>: <a href="/wiki/Temazepam" title="Temazepam">temazepam</a>, <a href="/wiki/Flunitrazepam" title="Flunitrazepam">flunitrazepam</a>, etc. As CD2, except witnessed destruction and CD register are not required.</li> <li><b>CD4</b>: <a href="/wiki/Benzodiazepines" class="mw-redirect" title="Benzodiazepines">benzodiazepines</a>, e.g. <a href="/wiki/Diazepam" title="Diazepam">diazepam</a>, <a href="/wiki/Nitrazepam" title="Nitrazepam">nitrazepam</a>, low dose <a href="/wiki/Methylphenobarbital" title="Methylphenobarbital">(methyl)phenobarbitone</a></li> <li><b>CD5</b>: low-dose <a href="/wiki/Codeine" title="Codeine">codeine</a>, etc.<sup id="cite_ref-24" class="reference"><a href="#cite_note-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup></li></ul> <div class="mw-heading mw-heading3"><h3 id="Myanmar_(Burma)"><span id="Myanmar_.28Burma.29"></span>Myanmar (Burma)</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=17" title="Edit section: Myanmar (Burma)"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The regulation of drugs in Burma is governed by the <a href="/wiki/Food_and_Drug_Administration_(Burma)" class="mw-redirect" title="Food and Drug Administration (Burma)">Food and Drug Administration (Burma)</a> and <a href="/wiki/Food_and_Drug_Board_of_Authority" title="Food and Drug Board of Authority">Food and Drug Board of Authority</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Norway">Norway</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=18" title="Edit section: Norway"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Medicines in Norway are regulated by the <a href="/wiki/Norwegian_Medical_Products_Agency" title="Norwegian Medical Products Agency">Norwegian Medical Products Agency</a>. Drugs are divided into five groups: </p> <dl><dd><b>Class A</b></dd></dl> <p>Narcotics, sedative-hypnotics, and amphetamines in this class require a <a href="/wiki/Special_prescription_form" title="Special prescription form">special prescription form</a>: </p> <ul><li><a href="/wiki/Morphine" title="Morphine">morphine</a> and its immediate family, <a href="/wiki/Heroin" title="Heroin">heroin</a>, <a href="/wiki/Desomorphine" title="Desomorphine">desomorphine</a>, <a href="/wiki/Nicomorphine" title="Nicomorphine">nicomorphine</a>;</li> <li><a href="/wiki/Codeine" title="Codeine">codeine</a> and its immediate family, <a href="/wiki/Dihydrocodeine" title="Dihydrocodeine">dihydrocodeine</a>, <a href="/wiki/Ethylmorphine" title="Ethylmorphine">ethylmorphine</a>, <a href="/wiki/Nicocodeine" title="Nicocodeine">nicocodeine</a>;</li> <li>morphine relatives: <a href="/wiki/Hydromorphone" title="Hydromorphone">hydromorphone</a> and <a href="/wiki/Oxymorphone" title="Oxymorphone">oxymorphone</a>;</li> <li>codeine relatives: <a href="/wiki/Hydrocodone" title="Hydrocodone">hydrocodone</a> and <a href="/wiki/Oxycodone" title="Oxycodone">oxycodone</a>;</li> <li>synthetic <a href="/wiki/Opioids" class="mw-redirect" title="Opioids">opioids</a>: <a href="/wiki/Pethidine" title="Pethidine">pethidine</a>, <a href="/wiki/Methadone" title="Methadone">methadone</a>, <a href="/wiki/Fentanyl" title="Fentanyl">fentanyl</a>, and <a href="/wiki/Levorphanol" title="Levorphanol">levorphanol</a>;</li> <li>various <a href="/wiki/Hypnotic" title="Hypnotic">sedative-hypnotics</a>: <a href="/wiki/Temazepam" title="Temazepam">temazepam</a>, <a href="/wiki/Methaqualone" title="Methaqualone">methaqualone</a>, <a href="/wiki/Pentobarbital" title="Pentobarbital">pentobarbital</a>, and <a href="/wiki/Secobarbital" title="Secobarbital">secobarbital</a>;</li> <li>various <a href="/wiki/Stimulant" title="Stimulant">stimulants</a>: <a href="/wiki/Amphetamine" title="Amphetamine">amphetamines</a> and <a href="/wiki/Methylphenidate" title="Methylphenidate">methylphenidate</a>;</li> <li><a href="/wiki/Flunitrazepam" title="Flunitrazepam">flunitrazepam</a> (moved from class B)</li></ul> <dl><dd><b>Class B</b></dd></dl> <p>Restricted substances which easily lead to addiction like: <a href="/wiki/Co-codamol" class="mw-redirect" title="Co-codamol">co-codamol</a>, <a href="/wiki/Tramadol" title="Tramadol">tramadol</a>, <a href="/wiki/Diazepam" title="Diazepam">diazepam</a>, <a href="/wiki/Nitrazepam" title="Nitrazepam">nitrazepam</a> and all other <a href="/wiki/Benzodiazepine" title="Benzodiazepine">benzodiazepines</a> (with the exception of temazepam and <a href="/wiki/Flunitrazepam" title="Flunitrazepam">flunitrazepam</a>) <a href="/wiki/Phentermine" title="Phentermine">phentermine</a>. </p> <dl><dd><b>Class C</b> - All prescription-only substances</dd></dl> <dl><dd><b>Class F</b> - Substances and package-sizes not requiring a prescription</dd></dl> <dl><dd><b>Unclassifieds</b> - Brands and packages not actively marketed in Norway</dd></dl> <div class="mw-heading mw-heading3"><h3 id="Philippines">Philippines</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=19" title="Edit section: Philippines"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The <a href="/wiki/Food_and_Drug_Administration_(Philippines)" title="Food and Drug Administration (Philippines)">Food and Drug Administration</a> regulates drugs and medical devices in the <a href="/wiki/Philippines" title="Philippines">Philippines</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Sri_Lanka">Sri Lanka</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=20" title="Edit section: Sri Lanka"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Prohibited. Brands and packages not actively marketed in Sri Lanka.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (April 2022)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading3"><h3 id="Switzerland">Switzerland</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=21" title="Edit section: Switzerland"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Medicines in Switzerland are regulated by <a href="/wiki/Swissmedic" title="Swissmedic">Swissmedic</a>. The country is not part of the <a href="/wiki/European_Union" title="European Union">European Union</a>, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (January 2014)">citation needed</span></a></i>]</sup> </p><p>There are five categories from A to E to cover different types of delivery category:<sup id="cite_ref-25" class="reference"><a href="#cite_note-25"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup> </p> <ul><li>A: Supply once with a prescription from a doctor or veterinarian</li> <li>B: Supply with a prescription from a doctor or veterinarian</li> <li>C: Supply on technical advice from medical staff</li> <li>D: Supply on technical advice</li> <li>E: Supply without technical advice</li></ul> <div class="mw-heading mw-heading3"><h3 id="United_Kingdom_2">United Kingdom</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=22" title="Edit section: United Kingdom"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Medicines for Human Use in the United Kingdom are regulated by the <a href="/wiki/Medicines_and_Healthcare_products_Regulatory_Agency" title="Medicines and Healthcare products Regulatory Agency">Medicines and Healthcare products Regulatory Agency</a> (MHRA). The availability of drugs is regulated by classification by the MHRA as part of marketing authorisation of a product.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p><p>The United Kingdom has a three-tiered classification system:<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p> <ul><li>General Sale List (GSL)</li> <li>Pharmacy medicines (P)</li> <li>Prescription Only Medicines (POM)</li></ul> <p>Within POM, certain agents with a high abuse/addiction liability are also separately scheduled under the <a href="/wiki/Misuse_of_Drugs_Act_1971" title="Misuse of Drugs Act 1971">Misuse of Drugs Act 1971</a> (amended with the Misuse of Drugs Regulations 2001); and are commonly known as <a href="/wiki/Controlled_Drug_in_United_Kingdom" class="mw-redirect" title="Controlled Drug in United Kingdom">Controlled Drugs</a> (CD). </p> <div class="mw-heading mw-heading3"><h3 id="United_States_2">United States</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=23" title="Edit section: United States"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Therapeutic goods in the United States are regulated by the <a href="/wiki/U.S._Food_and_Drug_Administration" class="mw-redirect" title="U.S. Food and Drug Administration">U.S. Food and Drug Administration</a> (FDA), which makes some drugs available <a href="/wiki/Over-the-counter_drug" title="Over-the-counter drug">over the counter</a> (OTC) at retail outlets and others by <a href="/wiki/Prescription_drug" title="Prescription drug">prescription only</a>.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p><p>The prescription or possession of some substances is controlled or prohibited by the <a href="/wiki/Controlled_Substances_Act" title="Controlled Substances Act">Controlled Substances Act</a>, under the FDA and the <a href="/wiki/Drug_Enforcement_Administration" title="Drug Enforcement Administration">Drug Enforcement Administration</a> (DEA). Some US <a href="/wiki/U.S._state" title="U.S. state">states</a> apply more stringent limits on the prescription of certain controlled substances C-V and BTC (behind the counter) drugs such as <a href="/wiki/Pseudoephedrine" title="Pseudoephedrine">pseudoephedrine</a>. Three primary branches of <a href="/wiki/Pharmacovigilance" title="Pharmacovigilance">pharmacovigilance</a> in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as <a href="/wiki/Research_on_Adverse_Drug_events_And_Reports" class="mw-redirect" title="Research on Adverse Drug events And Reports">RADAR</a> and <a href="/wiki/Public_Citizen" title="Public Citizen">Public Citizen</a>).<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=24" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/Council_for_International_Organizations_of_Medical_Sciences" title="Council for International Organizations of Medical Sciences">Council for International Organizations of Medical Sciences</a> (CIOMS, WHO)</li> <li><a href="/wiki/Counterfeit_drug" class="mw-redirect" title="Counterfeit drug">Counterfeit drug</a></li> <li><a href="/wiki/Drug_Efficacy_Study_Implementation" title="Drug Efficacy Study Implementation">Drug Efficacy Study Implementation</a> (DESI)</li> <li><a href="/wiki/Drug_policy" title="Drug policy">Drug policy</a> and <a href="/wiki/Drug_prohibition_law" class="mw-redirect" title="Drug prohibition law">Drug prohibition law</a></li> <li><a href="/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use" class="mw-redirect" title="International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use</a></li> <li><a href="/wiki/Inverse_benefit_law" title="Inverse benefit law">Inverse benefit law</a></li> <li><a href="/wiki/List_of_stringent_regulatory_authorities" title="List of stringent regulatory authorities">List of stringent regulatory authorities</a></li> <li><a href="/wiki/Over-the-counter_drug" title="Over-the-counter drug">Over-the-counter drug</a></li> <li><a href="/wiki/Prescription_drug" title="Prescription drug">Prescription drug</a></li> <li><a href="/wiki/Uppsala_Monitoring_Centre" title="Uppsala Monitoring Centre">Uppsala Monitoring Centre</a> (WHO)</li> <li><a href="/wiki/Validation_(drug_manufacture)" title="Validation (drug manufacture)">Validation (drug manufacture)</a></li> <li><a href="/wiki/World_Health_Organization" title="World Health Organization">World Health Organization</a></li> <li><a href="/wiki/Legal_drug_trade" title="Legal drug trade">Legal drug trade</a></li> <li><a href="/wiki/Illegal_drug_trade" title="Illegal drug trade">Illegal drug trade</a></li></ul> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regulation_of_therapeutic_goods&action=edit&section=25" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist"> <div class="mw-references-wrap mw-references-columns"><ol class="references"> <li id="cite_note-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite id="CITEREFSilver2017" class="citation news cs1">Silver, Carly (10 January 2017). 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rel="nofollow" class="external text" href="https://web.archive.org/web/20081019024756/http://www.ubio.in/diagnostics/drug-license-audit-in-india-things-to-remember/">Presentation on Drug License Audit Process in India</a></li></ul> <p><br /> </p> <div class="navbox-styles"><style data-mw-deduplicate="TemplateStyles:r1129693374">.mw-parser-output .hlist dl,.mw-parser-output .hlist ol,.mw-parser-output .hlist ul{margin:0;padding:0}.mw-parser-output .hlist dd,.mw-parser-output .hlist dt,.mw-parser-output .hlist li{margin:0;display:inline}.mw-parser-output .hlist.inline,.mw-parser-output .hlist.inline dl,.mw-parser-output .hlist.inline ol,.mw-parser-output .hlist.inline ul,.mw-parser-output .hlist dl dl,.mw-parser-output .hlist dl ol,.mw-parser-output .hlist dl ul,.mw-parser-output .hlist ol dl,.mw-parser-output .hlist ol ol,.mw-parser-output .hlist ol ul,.mw-parser-output .hlist ul dl,.mw-parser-output .hlist ul ol,.mw-parser-output .hlist ul ul{display:inline}.mw-parser-output .hlist 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