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Clinical Trials Directive
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<h2 id="the-articles-of-the-directive">The Articles of the Directive</h2> <p>The Articles of the Directive: </p> <ul><li>Scope (Directive does not apply to non-interventional trials).</li> <li>Definitions</li> <li>Protection of clinical trial subjects</li> <li>Clinical trials on minors</li> <li>Clinical trials on incapacitated adults not able to give informed legal consent</li> <li><a href="/facts/Ethics_Committee_(European_Union)/Mumqkfk8">Ethics Committee</a></li> <li>Single opinion</li> <li>Detailed guidance</li> <li>Commencement of a clinical trial</li> <li>Conduct of a clinical trial</li> <li>Exchange of information</li> <li>Suspension of the trial or infringements</li> <li>Manufacture and import of investigational medicinal products</li> <li>Labelling</li> <li>Verification of compliance of investigational medicinal products with good clinical and <a href="/facts/Good_Manufacturing_Practice/s4sETf1y">manufacturing practice</a></li> <li>Notification of <a href="/facts/Adverse_event/6zKwT4g5">adverse events</a></li> <li>Notification of <a href="/facts/Serious_adverse_event/9RARhzom">serious adverse reactions</a></li> <li>Guidance concerning reports</li> <li>General provisions</li> <li>Adaptation to scientific and technical progress</li> <li>Committee procedure</li> <li>Application</li> <li>Entry into force</li> <li>Addressees</li></ul> <h2 id="the-effects-of-the-directive">The effects of the directive</h2> <p>It increased the costs of doing clinical trials in the EU, and a reduction in the number of such trials followed its implementation,<a class="footnote-ref" id="fnref:2" href="#fn:2"><sup>2</sup></a> especially of academic-led studies, and ones looking at new uses for old drugs.<a class="footnote-ref" id="fnref:3" href="#fn:3"><sup>3</sup></a> Germany derogated from the directive.<a class="footnote-ref" id="fnref:4" href="#fn:4"><sup>4</sup></a> It is due to be replaced by the EU Clinical Trials Regulation in 2016.<a class="footnote-ref" id="fnref:5" href="#fn:5"><sup>5</sup></a> The changes are due to come into effect in the second half of 2019.<a class="footnote-ref" id="fnref:6" href="#fn:6"><sup>6</sup></a> </p> <h2 id="see-also">See also</h2> <ul><li><a href="/facts/EudraLex/kwrGuDQm">EudraLex</a>, the collection of rules and regulations governing medicinal products in the European Union</li> <li><a href="/facts/Directive_65/65/EEC1/UbN5wqMd">Directive 65/65/EEC1</a>, requires prior approval for marketing of proprietary medicinal products</li> <li><a href="/facts/Directive_75/318/EEC/lIxEktAc">Directive 75/318/EEC</a>, clarifies requirements of 65/65/EEC1 and requires member states to enforce them</li> <li><a href="/facts/Directive_75/319/EEC/UksB1gUR">Directive 75/319/EEC</a>, requires marketing authorisation requests to be drawn up only by qualified experts</li> <li><a href="/facts/Directive_93/41/EEC/3oxyt7Vw">Directive 93/41/EEC</a>, establishes the European Agency for the Evaluation of Medicinal Products</li> <li><a href="/facts/Directive_2001/20/EC/dr6DMsSR">Directive 2001/20/EC</a>, defines rules for the conduct of <a href="/facts/Clinical_trials/q8LMr832">clinical trials</a></li> <li><a href="/facts/Directive_2001/83/EC/y5sBg1nI">Directive 2001/83/EC</a></li> <li><a href="/facts/Directive_2005/28/EC/LntExPqv">Directive 2005/28/EC</a>, defines Good Clinical Practice for design and conduct of clinical trials</li> <li><a href="/facts/European_Medicines_Agency/h9FTtCYc">European Medicines Agency</a></li> <li><a href="/facts/Regulation_of_therapeutic_goods/ekrFg7EP">Regulation of therapeutic goods</a></li> <li><a href="/facts/Investigator%27s_Brochure/w24LeYlX">Investigator's Brochure</a></li></ul> <ul><li><a href="http://ec.europa.eu/health/human-use/clinical-trials/">EU information on the Clinical Trials Directive</a></li></ul> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>https://eur-lex.europa.eu/eli/reg/2014/536/oj/eng <a href="https://eur-lex.europa.eu/eli/reg/2014/536/oj/eng" target="_blank">https://eur-lex.europa.eu/eli/reg/2014/536/oj/eng</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly <a href="http://vertassets.blob.core.windows.net/download/a78320af/a78320af-1b65-4bbe-b603-bb0540285015/synhcr_eu_ct_regulation.pdf" target="_blank">http://vertassets.blob.core.windows.net/download/a78320af/a78320af-1b65-4bbe-b603-bb0540285015/synhcr_eu_ct_regulation.pdf</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>A Dalgleish (8 October 2016). "We can now revive clinical trials killed by the EU". The Daily Telegraph. London. p. 21.print and online <a href="https://www.telegraph.co.uk/news/2016/10/07/brexit-means-we-can-revive-clinical-trials-killed-by-the-eu/" target="_blank">https://www.telegraph.co.uk/news/2016/10/07/brexit-means-we-can-revive-clinical-trials-killed-by-the-eu/</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>A Dalgleish (8 October 2016). "We can now revive clinical trials killed by the EU". The Daily Telegraph. London. p. 21.print and online <a href="https://www.telegraph.co.uk/news/2016/10/07/brexit-means-we-can-revive-clinical-trials-killed-by-the-eu/" target="_blank">https://www.telegraph.co.uk/news/2016/10/07/brexit-means-we-can-revive-clinical-trials-killed-by-the-eu/</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly <a href="http://vertassets.blob.core.windows.net/download/a78320af/a78320af-1b65-4bbe-b603-bb0540285015/synhcr_eu_ct_regulation.pdf" target="_blank">http://vertassets.blob.core.windows.net/download/a78320af/a78320af-1b65-4bbe-b603-bb0540285015/synhcr_eu_ct_regulation.pdf</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> <li id="fn:6"><p>"European Medicines Agency - Clinical trials - Clinical Trial Regulation". ema.europa.eu. Archived from the original on 15 March 2018. <a href="https://web.archive.org/web/20180315003521/http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp&mid=WC0b01ac05808768df" target="_blank">https://web.archive.org/web/20180315003521/http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp&mid=WC0b01ac05808768df</a> <a href="#fnref:6" class="footnote-back-ref">↩</a></p></li> </ol>