Where is European Regulation 536/2014 Taking Us?

European Parliament and Council of the European Union. Regulation (EU) No 536/2014 … on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC. Off J Eur Union (2014), 27 May 2014 (henceforth Reg 536/2014). See: http://data.europa.eu/eli/reg/2014/536/2022-12-05 (accessed 21 Jun 2023) for its Preamble and Articles (Arts.) cited below.

EU Regulation 536/2014, Art. 38

Reg 536/2014, Preamble, paras 4 and 81

Reg 536/2014, preamble, para (4)

Dyck M, Allen G. Is mandatory research ethics reviewing ethical? J Med Ethics. 2013;39:517–20.

Reg 536/2014, Art.6, para 1(a)

Reg 536/2014, Arts.8 para 2(b); Art. 90

Reg 536/2014, Art.78, paras 1-7

Reg 536/2014, Arts. 86, 87, 94

Commission Decision (EU) 2021/1240. Off J Eur Union L 275/1, 13 July 2021