New Clinical Trials Regulation in Europe

December 2, 2021

On 31 January 2022, Clinical Trials Regulation (Regulation (EU) No 536/2014) will go live, repealing EU Clinical Directive (EC No 2001/20/EC) and changing how Clinical Trials are conducted in the European Union (EU).

The European Medicine Agency (EMA) has set up the Clinical Trials Information System (CTIS) to centralize all information and databases associated with clinical trials conducted in the EU. Using the CTIS, the new Regulation will, in particular, harmonize the submission and evaluation of clinical trials across Member States, as well as facilitate the sharing of safety information and increase the level of transparency. On Monday 29 November, the EMA introduced the key points of the new Regulation in a presentation for small and medium-sized enterprises, including providing details on the transition periods for ongoing clinical trials initiated under the previous clinical Directive. A large panel of training documentation is also available on the EMA website (https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation).

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