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Clinical Trials Regulation: A Further Step towards Increased Medical Innovation in the EU
Published online by Cambridge University Press: 20 January 2017
Abstract
On 27 May 2014, after two years of debates and extensive amendments by the EU’s law-making institutions, the EU Clinical Trial Regulation1 was published. The Regulation repeals and replaces the Clinical Trials Directive, an instrument described by the European Commission as “arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals”. The Clinical Trials Regulation is intended to improve the existing framework, and will become applicable at the earliest on 28 May 2016. This report reviews the most significant changes to the existing system brought about by the Clinical Trials Regulation, and how this Regulation purports to strike a balance between its objective of increasing clinical trial activity in the EU and the need to protect clinical trial subjects’ rights, safety and well-being.
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References
1 Regulation (EU) 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1 (the “Clinical Trials Regulation” or the “Regulation”).
2 Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121, 1.5.2001, p. 34, as amended (the “Clinical Trials Directive” or the “Directive”).
3 European Commission, Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, COM (2012) 369 final, section 1.
4 See e.g. statement released as part of the CLINT Project (Establishment of infrastructure to support International Prospective Clinical Trials in Stem Cell Transplantation) at http://www.ebmt.org/sites/clint2/clint/Lists/News/DispForm.aspx?ID=5&ContentTypeId=0x010400DBE31DC8D6E8F84BB37B4D1B0382F985 (accessed on 19 June 2015).
5 Clinical Trials Directive, Article 9(2).
6 Clinical Trials Regulation, Article 5.
7 Clinical Trials Regulation, Article 6(5).
8 Clinical Trials Directive, Article 9(4).
9 Clinical Trials Regulation, Articles 6-7.
10 European Commission, “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)”, OJ C 172, 11.6.2011, p. 1.
11 Clinical Trials Directive, Article 17.
12 ICH, Guideline for Good Clinical Practice (E6 – the “ICH GCP”).
13 European Commission, “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)”, OJ C 82, 30.3.2010, p. 1.
14 Clinical Trials Regulation, Article 48; ICH, Guideline for Good Clinical Practice (E6), Section 5.18.
15 Clinical Trials Regulation, Article 29; Clinical Trials Directive, Articles 2(j) and 3; ICH GCP, Section 4.8.10.
16 Clinical Trials Regulation, Article 4 and Preamble, Recital 18.
17 Clinical Trials Directive, Article 1(1) ; Clinical Trials Regulation, Article 1.
18 See e.g. Articles 29(7), 29(8) and Article 34.
19 Clinical Trials Regulation, Annex I, sections K-Q.
20 Clinical Trials Regulation, Article 37(4).
21 Clinical Trials Regulation, Article 94(2).
22 See e.g. http://www.alltrials.net/news/europe-votes-for-clinical-trial-transparency/ (accessed on 18 June 2015).
23 See European Medicines Agency, “Questions and answers on the European Medicines Agency Policy on Publication of Clinical Data for Medicinal Products for Human Use”, EMA/357536/2014 Rev. 1, p. 7.
24 See e.g. the sponsors listed on https://www .clinicalstudydatarequest.com/ (accessed on 18 June 2015).
25 European Medicines Agency, “Policy on Publication of Clinical Data for Medicinal Products for Human Use”, EMA/240810/2013.
26 European Medicines Agency, “Functional specifications for the EU portal and EU database to be audited”, EMA/42176/2014 Rev. 1.