01 October 2025
EMA/INS/GMP/369445/2024
EMA Inspections Office
From now on, EU and FDA regulators can rely on each other’s GMP inspections not only within their territories but also outside the EU and US; a huge leap towards global inspection efficiency and reduced duplication of audits.
As of 1 November 2017, for human medicines and 30 May 2023 for veterinary products, the EU Member States will not duplicate inspections conducted by the FDA. At the same time, it is expected that the FDA will not duplicate inspections conducted by a recognised authorityi
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Exceptionally, both the EU and FDA reserve the right to inspect in each other’s territory at any time.