European Medicines Agency And US Food And Drug Administration Increase Pharmacovigilance Cooperation

On 19 February 2014, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) announced they had established a new "cluster" in the area of pharmacovigilance. The cluster will have monthly teleconferences to exchange information on the safety of medicines and coordinate communication activities. In particular, the cluster will allow the regulators "systematic and focused" discussion on topics requiring an "intensified exchange of information and collaboration". Canadian and Japanese regulatory authorities will participate in the meetings of the cluster on pharmacovigilance as observers.

EMA's Executive Director Guido Rasi stated: "In an increasingly globalised pharmaceutical market, collaboration between medicines' regulators is essential...