Mutual recognition with the United States

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Authorities in the European Union (EU) and the United States (US) have put in place a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections. The aim of the agreement is to encourage greater international harmonisation, make better use of inspection capacity and reduce duplication.

The EU and US signed the MRA on GMP inspections in February 2017, which enters into force on 1 November 2017.

The agreement is a sectoral annex of the broader EU-US MRA, signed in 1998 between the EU and US authorities. This covers various economic sectors, but recognition in the area of pharmaceutical manufacturing practices was not implemented prior to the MRA on GMP inspections.

The text of the updated MRA is available on the European Commission’s website.

The MRA will allow EU authorities and their US counterparts to:

  • rely on each other's GMP inspections;
  • waive any requirements for batch testing of products on entry into their territories, after a transition phase;
  • share information on inspection outcomes and quality defects.

The EU and the US have comparable regulatory and procedural frameworks for inspections. They also cooperate in projects and initiatives for harmonising GMP inspections at international level. For more information, see GMP compliance: coordination of GMP inspections and Partners and networks: United States.

Transition phase

The authorities will assess each other's pharmaceutical legislation, guidance documents and regulatory systems as part of the agreement. 

As the US Food and Drug Administration (FDA) will assess each EU Member State authority individually, a transition phase will be in place until July 2019.

Imported products still need to be batch tested until this requirement is waived after the transition phase.

Products covered by the MRA

The EU-US MRA covers:

  • finished pharmaceutical forms of human medicines;
  • intermediate (in the EU) and in-process (in the US) products;
  • certain marketed biological products for human use;
  • active pharmaceutical ingredients.

It excludes medicines derived from blood or blood plasma, human tissues and organs and veterinary immunologicals.

During the transition phase, authorities will decide whether to include veterinary medicines, vaccines and plasma-derived medicines.

The MRA normally covers pre-approval inspections, although special provisions apply during the transition phase, which EMA and FDA may review. For more information, see Article 20 of the MRA. 

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