FDA, EMA to work together on pharmacovigilance

February 20, 2014

FDA plans to work closely with the European Medicines Agency (EMA) to ensure the safety of medicines, according to a Feb. 19 announcement.

FDA plans to work closely with the European Medicines Agency (EMA) to ensure the safety of medicines, according to a Feb. 19 announcement.

FDA and EMA will meet monthly via teleconference through “a new cluster on pharmacovigilance topics,” which are specific topic areas that need greater attention through an exchange of information and collaboration with regulators outside of the European Union.

FDA and EMA have already established clusters for discussions about biosimilars, cancer treatment drugs, orphan drugs, children’s medicines, and blood-based products. Canadian and Japanese regulators have also been involved in some of these discussions, FDA noted.

“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. “It is part of a larger collaborative global effort between FDA and its international regulatory partners to ensure the health and safety of all our citizens.”

This collaboration is necessary to ensure the safety and quality of drugs throughout the world. The new pharmacovigilance cluster should help to “keep medicines safe, regardless of location.” All information exchanged between FDA and EMA will be kept confidential.