EMA: Reliance on FDA Inspections Outside the United States
Starting 1 October 2025, the European Medicines Agency (EMA) has begun accepting FDA inspection findings for manufacturing sites located outside the United States. The decision follows a successful pilot under the EU–US Mutual Recognition Agreement (MRA).
EU authorities may now, after a case-by-case and risk-based assessment, rely on FDA inspections and postpone planned EU inspections during marketing authorization or variation procedures.
Applicants are encouraged to submit FDA inspection reports proactively to facilitate the use of this new reliance mechanism.
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