EMA/CHMP marketing authorization recommendations rises one third on last year

1 August 2013

The European Medicines Agency says that 44 medicines have been recommended for marketing authorization by its Committee for Medicinal Products for Human Use (CHMP), compared with 33 by the same time last year.

While the number of generics is stable, the number of medicines containing new active substances is higher than last year, with 20 medicines containing active substances that had never been used in medicines before.

The EMA said almost one in every two applicants received scientific advice from the agency’s CHMP during the development phase of their medicines. Seeking and following scientific advice has been proven to significantly increase the probability of a positive outcome. A study has shown that the approval rate is 90% when sponsors comply with scientific advice compared with 30% when they do not.

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





Today's issue

Company Spotlight





More Features in Pharmaceutical