Revising the guideline on first-in-human clinical trials.

The article informs about the changes made with the guidelines on first-in-human clinical trials by European Medicines Agency (EMA) with European Commission and members of European Union (EU). Topics include opening of EMA's revised guideline for public consultation until 28 February 2017; tragic incident took place during phase I first-in-human clinical trial in Rennes, France; role of non-clinical data in the definition of the estimated therapeutic dose, maximal dose, and dose intervals.