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null The EU and the USA reach a milestone on the mutual recognition of GMP inspections of pharmaceutical manufacturers

The EU and the USA reach a milestone on the mutual recognition of GMP inspections of pharmaceutical manufacturers

19.7.2019

The mutual recognition agreement (MRA) on GMP inspections between the EU and the USA became fully operational on 11 July 2019, after the US Food and Drug Administration (FDA) recognised that Slovakia, the last assessed EU country, has the capability to carry out mutual good manufacturing practice (GMP) inspections. 

After the agreement became fully operational, medicinal product batches imported from the USA do not have to be batch-tested in the EU, provided that they have been manufactured and tested in the United States. Batches still need to be certified and released by a Qualified Person (QP) who fulfils the criteria for pharmaceutical manufacturers based in the EU.

The agreement primarily concerns GMP inspections carried out by EU and FDA in their own territories, and covers the following medicinal product groups for human use: 

  • chemical pharmaceuticals;
  • medical gases;
  • biological medicines, including immunological products and products produced by recombinant DNA technology;
  • radiopharmaceuticals;
  • homeopathic and herbal medicines if classified as medicinal products;
  • vitamins;
  • minerals;
  • active pharmaceutical ingredients;
  • intermediates.

The expansion of the agreement to cover veterinary medicines will be assessed by 15 December 2019 and expansion to cover vaccines for human use and plasma-derived medicines by 15 July 2022. The inclusion of investigational medicinal products will be assessed at a later stage. Human blood and plasma, human tissues and organs, veterinary immunologicals and advanced therapy medicinal products have been excluded outside the agreement.

Read more:

Overview of the MRA agreement between the EU and the USA

EMA's press release, 12.7.2019

Q&A on the impact of the MRA between the EU and the USA

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  • Pirkko Puranen, senior inspector, tel. +358 29 522 3244
  • Email address format: firstname.lastname@fimea.fi