FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. 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. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

The FDA and the EMA have already set-up such clusters to discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children, blood-based products, among other topics. Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency are also involved in some of these clusters.

“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 shared pharmacovigilance issues 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 FDA’s and the EMA’s broader approach to expand and reinforce international collaboration.

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

This type of collaborative effort is important for ensuring the safety and quality of medicines distributed to consumers throughout the globe. The new cluster will help medicines’ regulators harmonize efforts to keep medicines safe, regardless of location.

Canadian and Japanese regulatory authorities will participate in the meetings of the cluster on pharmacovigilance as observers. The information exchange is covered by confidentiality arrangements between the FDA and the other participants.

For more information:

• FDA: Office of International Programs
• FDA: Office of Pharmacovigilance and Epidemiology
• FDA: Drug Safety Communications

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The European Medicines Agency is a decentralised agency of the European Union, located in London. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.