On May 27, 2016, the European Medicines Agency ("EMA") announced that it has started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. The review will identify which areas may need to be revised in the light of the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016. The trial led to the death of one participant and hospitalization of five others. EMA's review will take into account the findings from two in-depth investigations into what went wrong during this trial, one carried out by theTemporary Specialist Scientific Committee set up by the French medicines agency ANSM and the other by the Inspection générale des affaires sociales, the inspectorate for social affairs in France. Both reports include a series of recommendations regarding the requirements for authorization and conduct of first-in-human clinical trials for further examination by the international regulatory and public health community. The aim of EMA's work is to agree on a concept paper by July 2016 identifying areas for change and proposals to further minimize the risk of similar accidents. Meanwhile, French prosecutors have announced they have started an involuntary manslaughter investigation in connection with the incident.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.