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6th Vigilance Day
15 October 2019 - More information




Annual Report 2018


The U.S. Food and Drug Administration (U.S. FDA) has recognized all 28 EU member states. This means that starting 11 July 2019, the United States (US) and the European Union (EU) have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. 

During its meeting of July 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended new measures to avoid dosing errors with methotrexate. Furthermore, the PRAC started a review of meningioma risk with cyproterone medicines

Last updated on 29/06/2017