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It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States
It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States, in an April 30, 2019 press release from the European Medicines Agency (EMA).
The two European member states will now be included in the mutual recognition agreement between the European Union (EU) and the US, which mutually recognizes inspections of manufacturing sites for human medicines. As a result of the latest additions, FDA will now be able to rely on a total of 24 member states for equivalent GMP inspections.
EU member states and EMA have been able to rely upon inspections performed by FDA since Nov. 1, 2017. Further actions are underway to progress the agreement so that every member state of the EU will be included within the agreement, with a planned date of operation set at July 15, 2019.