¹ Council Regulation (EC) 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L158/1 (the “Clinical Trials Regulation” or the “Regulation”). It should be noted that the date of full implementation of the Regulation will depend on the operational readiness of the EU portal and database, maintained by the European Medicines Agency.

² Council Directive 2001/20/EC of 4 April 2001 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 L121/34, as amended (the “Clinical Trials Directive” or the “Directive”).

³ Regulation, Art 2.2(1).

⁴ Commission, “Health Commissioner, Tonio Borg, welcomes agreement on the revision of EU rules on Clinical Trials” (Memo) (2013) MEMO/13/1190.

⁵ 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, at p. 3. It should be pointed out that the development of the number of clinical trial applications was not uniformly negative across EU Member States. While there has been an overall decrease in both trial applications and conducted trials in the EU, some countries, notably Italy, have actually seen an increase in both numbers since the introduction of the Directive. See Markus Hartman, “Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries” (2012) 13 Trials 53.

⁶ MEMO/13/1190, supra note 4.

⁷ Regulation, Recital 5 (emphasis added).

⁸ For illustration, see e.g. Eva van Doorn et. al., “National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC” (2015) 3(2) Vaccines 263.

⁹ Regulation, Recital 4 (emphasis added).

¹⁰ Regulation, Art. 6.5.

¹¹ The Clinical Trials Regulation recognizes that the assessment of trials involving medicinal products from these categories may require additional expertise. To this effect, the Regulation provides for the RMS to extend the part I assessment process by an additional 50 days. See Regulation, Art. 6.7.

¹² Regulation, Art. 5.1.

¹³ Regulation, Art. 8.2.

¹⁴ Regulation, Recital 1.

¹⁵ Regulation, Art. 4.

¹⁶ Regulation, Art. 8.4.

¹⁷ Regulation, Art. 4.

¹⁸ Regulation, Recital 18.

¹⁹ Regulation, Art. 2.2(11).

²⁰ Consolidated version of the Treaty on the Functioning of the European Union [2008] OJ C115/01, Art. 5.

²¹ Regulation, Art. 4.

²² See David Shaw and David Townsend, “Division and Discord in the Clinical Trials Regulation” (2016) 42(11) Journal of Medical Ethics 729.

²³ Regulation, Art. 4.

²⁴ Regulation, Recital 18.

²⁵ If a trial involves medicinal products from certain technical categories, the RMS may extend the Part I assessment period by an additional 50 days. See supra note 12.

²⁶ Regulation, Recital 1.