Regulatory Focus™ > News Articles > Committee Calls for Improved Pharmacovigilance, New Labeling Requirements in Europe

Committee Calls for Improved Pharmacovigilance, New Labeling Requirements in Europe

Posted 17 May 2012 | By Alexander Gaffney, RAC 

The European Parliament's Environment, Public Health and Food Safety Committee (ENVI) is calling for new methods to monitor, label and withdraw dangerous medicines on an EU-wide basis.

Under new ENVI-backed legislation, any pharmaceutical product subject to a safety alert in one EU member state would trigger an automatic safety evaluation on an EU-wide level.

"The new proposal would introduce an emergency procedure to be triggered automatically if, for example, a Member State were to withdraw a medicinal product from the market," wrote ENVI in a statement. "This procedure could also be triggered if a company decided not to renew a marketing authorisation for safety reasons."

New labeling requirements would similarly come into effect under the new law and require any new or existing medicines with safety concerns to be labeled with a "black symbol" to allow for easy identification by EU consumers and physicians.

Companies recalling products from the market would also be required to notify regulatory authorities of the reason for withdrawing the products. ENVI said it hopes this provision will distinguish between companies withdrawing products for commercial concerns and those doing so for safety concerns.

The Committee's calls for change come after the French drug Mediator (benfluorex) was found to have remained on the French market for nearly a decade after being recalled from the markets of most other countries. The drug has been implicated in the unnecessary deaths of between 500 and 2,000 French citizens, which ENVI said show "the limits of the early EU pharmacovigilance system."

While new pharmacovigilance legislation is scheduled to come into implementation in 2012, the committee said it had "stress tested" the legislation, which uncovered gaps its new plan is intended to fill.

The vote on the proposed legislation is scheduled to occur during the European Parliament's 2-5 July session.


Read more:

European parliament - Towards better detection and EU-wide withdrawal of dangerous medicines

h/t Pharma Times - EU Parliament seeks urgent review of drug monitoring


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe