Snapshot

The USFDA-EMA Mutual Recognition Agreement for GMP Inspections pathway has been developed by the of United States.

This pathway can be used where Initially the agreement included only pharmaceuticals intended for human use. On May 31, 2023 the U.S. Food and Drug Administration (FDA) and the European Union (EU) announced their decision to expand the scope of the mutual recognition agreement to include inspections of veterinary pharmaceuticals..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA United States

Not applicable.