Clinical trials: new European regulation enters into force
January 31, 2022
On 31 January 2022, the Clinical Trials Regulation (CTR) 536/2014 on medicinal products for human use will enter into force. However, the old and the new legislation on clinical trials will coexist during a transition period of three years (until 31 January 2025).
Source: FAMHP
The new Clinical Trials Regulation (CTR)(link is external) will enter into force on 31 January 2022. This important change in legislation targets administrative simplification and harmonisation in Europe.
In order to facilitate the transition, both legislations - the old and the new - will coexist for a period of three years (until 31 January 2025).