CLINICAL TRIALS REGULATION:(EU) Nr. 536/2014. Clinical trials on medicinal products for human use.
DRAFT QUESTIONS & ANSWERS VERSION 3
Submitted for discussion to the Expert Group on Clinical Trials. febuary 2021.
The new Clinical Trials legislation has taken the legal form of a Regulation and will replace national law. This will ensure that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the EU.
This is vital to ensure that Member States, in authorising and supervising the conduct of a clinical trial, base themselves on the same rules.
The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. It will not only harmonize decisions, but also foster work sharing
and collaboration between Member States