The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency

The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical Trials Regulation 536/2014 (CTR). This eagerly awaited regulation came into application at the end of January 2022 with a three-year transition period. As discussed in this Foreword from Morgane Colin de Verdiere and Catriona Ester from the EMA, the new regulation will facilitate sponsors’ clinical trial applications in the EU while streamlining the assessment and supervision processes for regulatory authorities.

Medical Writing. 2023;32(1)8-10. https://doi.org/10.56012/grep1078