EMA planning fundamental change in pharmacovigilance rules

3 February 2012

The European Medicines Agency, together with the European Union member states and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Over the next five months, the Agency says it will finalize its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for July 19, 2012.

The EMA will continue to inform stakeholders of the ongoing implementation process through its web site and stakeholder meetings. This will include consultation and guidance on new or revised processes, information on transitional arrangements for the pharmaceutical industry, and information on how patients and health care professionals can be involved in the detection and management of safety issues in European member states. This information will complement the implementing measures being finalised by the European Commission.

CMDh mandate revised

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 Biotechnology