EU regulator's proposals to revise guidance on first-in-human clinical trials

21 July 2016
ema-big-1

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union, 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 September 30, 2016 using the form provided.

The EMA’s action was largely prompted by a Phase I clinical study, conducted by French clinical research organization Biotrial, recently resulted in the death of one enrolled subject and neurological injury to four others. The study had focused on BIA 10-2474, an Investigational New Drug (IND) manufactured by Portugal’s largest drugmaker Bial.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical