EMA and FDA partners in pharma safety

The EMA and FDA have announced plans for a new collaboration to strengthen their individual efforts towards maintaining medicine safety.

In a recently released joint statement, the European Medicines Agency (EMA) and the US Food and Drug Association (FDA) confirmed they are entering into a ‘cluster’ agreement to facilitate an “increased degree of interaction” to “work swiftly in the area of the safety of medicines”.

Under their new collaborative agreement, the two authorising bodies plan to hold monthly meetings via teleconferencing to share resources and information and discuss “areas that have been identified as requiring an intensified exchange of information and collaboration”.

As the EMA has made increased efforts in recent years to improve drug safety – including the launch of new legislation in 2012 – this collaboration will add further support to the Agency’s ongoing attempts to regulate medicines and reflects the global nature of the modern pharmaceutical industry.

Guido Rasi, executive director of the EMA, said: “Medicines’ regulators are interdependent; any action taken in one territory has repercussions on the rest of the world. International cooperation is a key area of work for the Agency.”

 The new pharmacovigilance ‘cluster’ – as the two agencies are deeming it – will also feature representatives from Canada and Japan in observatory roles. It is hoped that sharing resources and increasing communication will improve medicine safety throughout the world.

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June, 2014
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