Back to previous page

International cooperation increases in GMP inspections – Finland recognized in the MRA between the EU and the United States

International cooperation increases in GMP inspections – Finland recognized in the MRA between the EU and the United States

28.11.2018

In it's assessment, the United States Food and Drug Administration (FDA) concluded in November 2018 that Fimea has the capability for the mutual recognition of Good Manufacturing Practice (GMP) inspections of pharmaceutical manufacturers.

FDA’s assessment was part of the implementation of the Mutual Recognition Agreement (MRA) between the EU and the United States. In addition to Finland, FDA has to date confirmed the capability of 18 other EU Member States (Belgium, Denmark, Latvia, Portugal, Ireland, Lithuania, Czech Republic, Greece, Hungary, Romania, Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom) whose GMP inspections it can recognise. The EU already assessed and confirmed the capability of the US FDA in 2017. 

Mutual recognition and cooperation utilised in inspections

With the agreement, the EU Member States will no longer conduct duplicate inspections of manufacturers inspected by the FDA in the United States with regard to the groups of medicines covered by the agreement, and FDA is not expected to repeat inspections conducted in the EU by an authority it has recognised. However, both the EU and the FDA will exceptionally reserve the right to conduct inspections in each other’s territory at any time.

The Mutual Recognition Agreement primarily pertains to the GMP inspections conducted by the EU and the United States in their respective territories. However, in their supervision activities, the EU and the FDA may utilise the inspections conducted by the other on manufacturers located outside of the United States and the EU.

At this stage, the agreement covers the following groups of medicines intended for humans:

  • chemical pharmaceuticals;
  • medicinal 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;
  • intermediate products and bulk pharmaceuticals.

The objective is to extend the coverage of the agreement in the forthcoming years

The batch-specific quality control of medicinal product batches imported from the United States must still be conducted in the EU area. Quality control tests can only be waived when the FDA has confirmed the capability of all EU Member States for the mutual recognition of GMP inspections. According to the MRA, this should be accomplished no later than 15 July 2019.

The expansion of the agreement to cover veterinary medicines will be assessed by 15 July 2019 and 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:

GMP annex to the MRA between the EU and the USA

Further Information:

GMP@fimea.fi

Mervi Saukkosaari, Head of Division, Supervision and Licences, tel.  +358 29 522 3261

Share this page