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. Medicines' regulators are inter-dependent: 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 EMA and FDA have been cooperating under confidentiality agreements since 2003, but this latest pharmacovigilance cluster reflects the trend of growing international cooperation between regulatory authorities."