FDA and EMA Collaborate on Pharmacovigilance

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FDA and EMA set up regular meetings to harmonize drug safety actions.

FDA and the European Medicines Agency (EMA) have set up a regular collaborative meeting (cluster) to discuss pharmacovigilance (medicine safety) topics, building on previous regular videoconferences between FDA and EMA and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee. The cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines, and discussions on shared pharmacovigilance issues will take place between the agencies on a monthly basis by teleconference. The increased interaction will allow the agencies to work swiftly on issues of safety and to coordinate communication activities. The creation of this cluster is the latest step in FDA’s and EMA’s broader approach to expand and reinforce international collaboration. FDA hopes that the new cluster will help drug regulators harmonize efforts to keep medicines safe, regardless of location.

“The work of protecting the health and safety of the American people cannot be done in isolation,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

 “In an increasingly globalized pharmaceutical market, collaboration between medicines’ regulators is essential,” explained Guido Rasi, the EMA’s executive director, in the press release. “Medicines’ regulators are interdependent: 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.”

Canadian and Japanese regulatory authorities will observe pharmacovigilance cluster meetings. The information exchange is covered by confidentiality arrangements between FDA and the other participants.

Source: FDA.gov