FDA And EMA Step Up Collaboration In Pharmacovigilance

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have strengthened their collaboration in the area of pharmacovigilance by setting up new clusters on medicine safety topics, the FDA stated in a news release this week.

Clusters are comprised of regular collaborative meetings between the EMA and regulators outside the EU which focus on discussion of key topic areas. The clusters will build on the experience of previous regular videoconferences between the FDA and the EMA and complements the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee.

Previous clusters set up by the FDA and the EMA include discussion on issues related to cancer treatments, biosimilars, orphan medicines, pediatric medicines, and blood-based products, among others. Health Canada and Japanese Pharmaceuticals Medical Devices Agency have also participated in previous clusters. The new clusters will provide a forum for a “more systematic and focused exchange of information on the safety of medicines.”

Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research, said “The work of protecting the health and safety of the American people cannot be done in isolation… 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.”

EMA Executive Director Guido Rasi explained, “In an increasingly globalized 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.”

Discussions on shared key pharmacovigilance issues will take place on a monthly basis via teleconference between the agencies. Canadian and Japanese regulatory authorities will also participate in the meetings as observers, with all exchange of information covered by confidentiality agreements. The clusters will allow for coordination in communication activities between the agencies and underline efforts to expand international collaboration, the FDA said.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386372.htm