The FDA and EMA have confirmed the inclusion of Slovakia in the mutual recognition agreement. The activities of this country’s GMP inspectorate received a positive assessment.
The authorities announced this on Friday, July 12, before the deadline (July 15), which was set aside for all parties to sign the contract.
Now, the FDA has recognized the results of GMP inspections conducted by the inspectorates of all 28 EU member states.
The EMA, in turn, agreed with the FDA that the results of inspections carried out by inspectors from the United States would not require repeated inspections from the European regulator.
The process of mutual recognition of the results of GMP inspections has been developing since 1998, after the EU and the USA signed the mutual recognition agreement, which included a “pharmaceutical application”, according to which it was possible to rely, to a limited extent, on the results of inspections conducted by EU and US regulators, respectively.