Proposals to revise EU Guidance on first-in-human Clinical Trials

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until 30 September 2016.

The proposed changes take into account the evolution of practices in the conduct of first-in-human clinical trial studies and the lessons learnt from the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016.

The concept paper and the comments received from stakeholders will form the basis for an update of the guideline. A draft revised guideline is expected to be published before the end of 2016 for consultation.