EMA, FDA Form Pharmacovigilance Cluster

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-24-2014 13:05


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

Clusters are regular collaborative meetings between the EMA and regulators outsidie of the European Union that focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. The EMA and  FDA have already set up such clusters to discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children and blood-based products, among other topics. Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency are also involved in some of these clusters. 

As part of the new cluster, discussions on any pharmacovigilance issue 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 EMA’s and FDA’s wider approach to expand and reinforce international collaboration. The information exchange is covered by the confidentiality arrangements between the EMA and FDA. Canadian and Japanese regulatory authorities will participate in the meetings of the cluster on pharmacovigilance as observers.

Source: European Medicines Agency


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