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EMA and FDA create pharmacovigilance 'cluster'

Monthly meetings to discuss key issues in medicines safety
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The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) will strengthen their joint efforts on medicines safety through regular collaborative meetings.

The agencies, which respectively regulate drugs in the EU and US, announced a new pharmacovigilance 'cluster' to provide a forum to share information on the safety of medicines.

This cluster will involve monthly meetings via teleconference, during which agency representatives will discuss 'areas that have been identified as requiring an intensified exchange of information and collaboration'.

Representatives from the regulatory bodies of Canada and Japan will participate in these meetings as observers.

In a joint statement, the EMA and FDA said: '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 development follows heightened efforts in medicines safety from the EMA, centred around the launch of new pharmacovigilance legislation in 2012.

These rules include new powers for the EMA, allowing the 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 the EU.

In the 18 months since it launched, the PRAC has made safety recommendations on Ariad's cancer drug Iclusig (ponatinib) and Bayer's contraceptive Diane 35 (cyproterone acetate) among others.

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

EMA's executive director Guido Rasi explained more collaborative regulatory relationships were needed due to the increasingly globalised nature of the pharma industry.

“Medicines' regulators are inter-dependent: any action taken in one territory has repercussions on the rest of the world,” he explained. “International cooperation is a key area of work for the Agency.”

Article by
Thomas Meek

20th February 2014

From: Regulatory



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