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EMA: Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 24 Member States whose inspection results can replace their own inspections.

In June 2017, the European Commission confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since
1 November 2017, EU Member States and EMA can rely on inspection results from the FDA.

Actions for the agreement to be operational in all EU Member States are progressing.  The planned date of operation is 15 July 2019.The mutual recognition agreement between EU and US regulators strengthens reliance on each other’s inspection expertise and resources. Mutual benefits for EU authorities and the FDA include:

  • the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
  • prioritising inspections of medicines manufacturing sites for higher risk cases;
  • reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
  • improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk;
  • reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.

The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the FDA have been auditing and assessing the respective supervisory systems since May 2014, and are working closely together to reach the agreement’s milestones.

Posted on the EMA website on 30 April 2019

2019-05-05T21:14:04+00:0005.05.2019|Quality System and Audit, Regulatory Affairs|