Clinical trials: new European regulation enters into force

date: 31/01/2022

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).

The new Clinical Trials Regulation (CTR) 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).
This transition period consists of two stages.

  • Until 31 January 2023, sponsors will be able to choose whether to submit their initial files on clinical trials under the old or the new legislation.
  • During the following two years (from the 1 February 2023 till the 31 January 2025), clinical trials authorised under the old legislation may continue pursuant to the rules of that legislation until the end of the clinical trial or until its transition to the new legislation.

In order to better inform the stakeholders about the implementation of the new legislation and the different procedures, the webpage Clinical trials will be reorganised in the coming days. 

Last updated on 31/01/2022