Answer given by Ms Kyriakides on behalf of the European Commission
13.1.2022
Regulation (EU) No 536/2014[1] will become applicable on 31 January 2022. The regulation applies from that date onward to all clinical trials conducted in the EU that have been authorised under its principles. The clinical trials referred to with active clinical trial sites in Europe have been authorised under the principles of the current Directive 2001/20/EC[2].
Both the current and future rules for clinical trials in Europe require the sponsors of such clinical trials to respect the principles of good clinical practice[3]. These principles are a set of internationally recognised ethical and scientific quality requirements, which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of those participating in clinical trials are protected, and that the results of the clinical trials are credible.
The principles of good clinical practice need to be respected in every clinical trial that is part of an authorisation to market a medicinal product in the EU, even when the trial itself does not take part in the EU.