News about GMP/cGMP

16.07.2019

MRA EU/USA: Goal achieved - all EU member states recognized

As the EMA announced on 12 July 2019, Slovakia is the last EU member state to be recognized by the USA under the Mutual Recognition Agreement (MRA).

The US FDA now grants all 28 EU member states the ability to conduct GMP inspections at a level equivalent to that of the US. The authorities responsible in the USA and the EU no longer have to carry out their own inspections of manufacturing sites, but can rely on reliable inspection results from the other side. Thereby the deadline of 15 July 2019 has been met.

What are the benefits?

  • Capacities and resources will be freed up by avoiding double inspections.
  • Batch testing by qualified persons is no longer necessary.
  • Medicines can be brought onto the market faster and more cost-effectively.
  • High quality is guaranteed.

This is the result of five years of collaboration between teams from the European Commission, EU national authorities, the European Medicines Agency (EMA) and the US FDA. Work will continue to achieve application of the MRAs to veterinary medicines, human vaccines and plasma-derived medicines.

In order to achieve the goal of mutual recognition, the EMA has published a revised version of the Question and Answer Paper on the key issues of the MRA.


Sources:

EMA: EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers

EMA: Q&A on the impact of Mutual Recognition Agreement between the European Union and the United States

FDA: Mutual Recognition Agreement (MRA)

EC: Press release



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