EMA and FDA Create Pharmacovigilance Collaboration

EMA and FDA Create Pharmacovigilance CollaborationThe European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have announced that they will reinforce their efforts on medicines safety through regular collaborative meetings.

The regulatory agencies confirmed that they will be forming a new pharmacovigilance ‘cluster’ to provide an opportunity to share information on the safety of medicines.

The cluster will involve monthly meetings via a teleconference, during which representatives from the regulatory bodies will discuss ‘areas that have been identified as requiring an intensified exchange of information and collaboration’.

Representatives from Canada and Japan’s regulatory agencies will also participate in the meetings as observers.

In a joint statement, the EMA and FDA commented that “this increased degree of interaction will allow the agencies to work swiftly in the area of the safety of medicines and to coordinate communication activities.”

The announcement follows intensified efforts in medicines safety from the European Medicines Agency, focused around the launch of new pharmacovigilance legislation in 2012.

These rules include new powers for the European regulatory body, allowing the regulatory agency to ask for post-marketing safety and efficacy studies, and the creation of a Pharmacovigilance Risk Assessment Committee (PRAC) to recommend on drug safety issues in Europe.

The new collaboration helps build on these efforts, and the EMA and FDA have experience in similar arrangements for other regulatory issues, including biosimilars, orphan drugs and paediatric medicines.

The EMA’s executive director, Guido Rasi, explained more collaborative regulatory relationships were needed as a result of the increasingly globalised nature of the pharmaceutical industry.

“Medicines’ regulators are inter-dependent: any action taken in one territory has repercussions on the rest of the world,” Rasi noted.  Therefore “international cooperation is a key area of work for the Agency,” he concluded.


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