The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have published a paper setting out proposals for a transformation initiative of EU clinical trials.

The paper includes a roadmap with target dates for 2023 based on the European Pharmaceutical Strategy proposed by the Commission in 2020. One of the 10 key points of the project is the modernisation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E6 (R2) Guideline for Good Clinical Practice, which comes five years after its last revision.

For further information on this topic please contact Eline van Nimwegen or Magdalena Kotyrba-Hagenmaier at Eversheds Sutherland LLP by telephone (+49 89 54565 0) or email ([email protected] or [email protected]). The Eversheds Sutherland LLP website can be accessed at www.eversheds-sutherland.com.