Published by EMA on 19-Feb-2014


The European Medicines Agency (EMA) and the United States Food and Drug AdministrationExternal link icon (FDA) have set up a new ‘cluster’ on pharmacovigilance (medicine safety) 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 will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

Clusters are regular collaborative 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, medicines for children and blood-based products, among other topics. Health CanadaExternal link icon and the Japanese Pharmaceuticals and Medical Devices AgencyExternal link icon (PMDA) are also involved in some of these clusters.

“In an increasingly globalised pharmaceutical market, collaboration between medicines’ regulators is essential,” explains 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.”

“The work of protecting the health and safety of the American people cannot be done in isolation,” says Janet Woodcock, Director, M.D., director of the FDA’s Center for Drug Evaluation and Research. “It is part of a larger collaborative global effort between the FDA and its international regulatory partners to ensure the health and safety of all our citizens.”

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 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 creation of this cluster is the latest step in the EMA’s 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 regulatory authorities will participate in the meetings of the cluster on pharmacovigilance as observers.