|Council of the European Union, European Parliament
|Official Journal of the European Union
|L 158, Pages 1-76
|Blog & Commentary, Legislation, News, Policy-making
Regulation (EU) No 536/2014 - formally signed by the co-legislators on 16 April 2014 - concerning clinical trials on medicinal products for human use. It repeals Directive 2001/20/EC. This a text with EEA relevance. It is also known as the Clinical Trials Regulation (CTR).
Directive 2001/20/EC - also known as the Clinical Trials Directive - set out basic principles for conducting clinical trials of medicinal products. While it brought improvements in the safety and ethical soundness of clinical trials in the European Union (EU) and in the reliability of clinical trials data, this Act also arguably became the most heavily criticised piece of EU legislation in the area of pharmaceuticals. This criticism was voiced by all stakeholders - patients, industry, and academic research. The provisions of this Directive seemed to have hampered the conduct of clinical trials in the EU.
A draft Regulation revising these rules was tabled by the European Commission on 17 July 2012. It aimed to simplify the rules for conducting clinical trials, in an attempt to address divergent transposition and overcome what as deemed an unfavourable regulatory framework for clinical research. An informal agreement between the co-legislators on a compromise text for this file was reached on 12 December 2013. This was endorsed by the Parliament on 2 April 2014, followed by the Council at a meeting on 14 April 2014. The Act was formally signed by the co-legislators on 16 April 2014 and published in the Official Journal on 27 May 2014.
While the Regulation entered into force on 16 April 2014, the timing of its application depended on the development of a fully functional EU clinical trials portal and database. In April 2021, the EMA Management Board confirmed that the EU Portal and Database were fully functional. The publication of the subsequent Commission Notice happened on 31 July, fixing the date of applicability of the Clinical Trials Regulation on 31 January 2022.
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