Drug makers in the EU and U.S. may no longer be required to undergo separate GMP inspections by the FDA and the competent authorities in EU member states following an agreement by the EU and U.S. regulators to recognize each other’s inspections of pharmaceutical manufacturing sites within their own territories. In effect, the two regulators should only have to inspect those EU or U.S. pharmaceutical manufacturing sites that aren’t on their own soil under exceptional circumstances.
The FDA and the EU say removing the need to duplicate inspections of manufacturers that make drugs for either European or U.S. markets will reduce costs and free up resources for inspecting production sites in other countries that make APIs for either of the two markets.
The FDA and the EU have been working together since 2014 to evaluate the potential for mutual recognition of their GMP inspections as part of the Mutual Reliance Initiative. The assessment and audit process involved the EC, EU national competent authorities, the European Medicines Agency, and the FDA. The resulting agreement represents an update to the US-EU Mutual Recognition Agreement (MRA).
The EU points out it already has mutual recognition agreements relating to GMP inspections with other countries, including Australia, New Zealand, Japan, and Switzerland.