EMA and FDA Extend Cooperation on Pharmacovigilance

The European Medicines Agency (EMA) and the FDA have set up a new cluster on pharmacovigilance topics. Building on the experience of previous regular videoconferences between the EMA and the FDA in this area and the recent creation of the EMA's dedicated committee for pharmacovigilance, the Pharmacovigilance Risk Assessement Committee (PRAC), this cluster aims to provide a forum for exchange of information on the safety of medicines.

“In an increasingly globalized pharmaceutical market, collaboration between medicines’ regulators is essential,” said the EMA’s Executive Director Guido Rasi. “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.”

As part of the new cluster, discussions on any pharmacovigilance issue will now take place between the agencies on a monthly basis by teleconference. This interaction will allow the agencies to work swiftly in the area of the safety of medicines and to coordinate communication activities.

The creation of this cluster is the latest step in the EMA and FDA’s wider approach to expand and reinforce international collaboration. The information exchange is covered by the confidentiality arrangements between the EMA and FDA. Canadian and Japanese regulators will participate in the meetings of the cluster on pharmacovigilance as observers​.

Clusters comprise regular meetings between the EMA and regulators outside of the European Union which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. The EMA and the FDA have already set up such clusters to discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, and medicines for children and blood-based products. Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are also involved in some of these clusters.