Pharmacy Daily | FDA & EMA to ‘cluster’

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have set up a cluster on pharmacovigilance topics. The monthly teleconference meetings on shared pharmacovigilance issues would focus on topic areas needing more exchange of information and collaboration, the FDA said, which would allow the agencies to work faster in the area and coordinate communications. “This cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.” It builds on video conferences between the two regulatory bodies which were previously held in this area, and the creation of the EMA’s Pharmacovigilance Risk Assessment Committee, the FDA said. Clusters already exist for issues such as medicines to treat cancer and orphan medicines, with Health Canada and other regulatory bodies involved, and Canadian and Japanese regulatory bodies would participate in the pharmacovigilance meetings as observers, the FDA said. FDA Centre for Drug Evaluation and Research director Jane Woodcock said the cluster was part of a larger collaborative effort between the FDA and international regulatory partners to ensure the health and safety of all citizens.

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