The proposed revision is open for public consultation until the end of February 2017
The European Medicines Agency (EMA), together with the European Commission and the Member States of the European Union has proposed changes to its existing guideline on first-in-human clinical trials. It has suggested these in order to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017.
The EMA has released a concept paper for public consultation between July and end of September 2016, EMA which outlined the major areas that needed to be revised in the guideline, to reflect the evolution of practices in the last ten years. The review also took into account 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 consultation of the concept paper served as the basis for the revision of the guideline, which was carried out by an EU-wide group made up of experts from the national competent authorities who authorise clinical trials in the EU. The draft revised guideline was adopted last week by EMA’s Committee for Medicinal Products for Human Use (CHMP).
This revised guideline is meant to address the increasing complexity of protocols of first-in-human clinical trials in recent years.
EMA will make available all comments received, both on the concept paper and the revised guideline, after the final guideline is released. The aim is to publish a final revised guideline for the conduct of first-in-human clinical trials in the first half of 2017.
The draft guidelines can be found here.