Do you know? To rely on each other’s Good Manufacturing Practice (GMP) inspections pertaining to human medicines, the European Union (EU) and the United States (US) have signed a Mutual Recognition Agreement (MRA) in 1998. However, despite a series of actions and progressive discussions, it was never operational. But the talks which began in 2014 led to revision of Annex in 2017. As a result, on Nov 1, 2017, the agreement was brought into force that helped both the territories to recognize each other’s inspection expertise and resources.

Now, with the US Food and Drug Administration’s (US FDA’s) recognition of Slovakia in July 2019, the EU and the US have taken the MRA to a new height and implemented it to a full extent. That means that the US and the EU can now rely on inspection results of both the territories instead of carrying out Good Manufacturing Practice (GMP) inspections  individually. Both the territories have agreed that each other’s capabilities, capacities and inspection procedures are equivalent and can rely on them.

This collaboration between the two territories is a testimony to the importance of the EU’s strategic partnership with the US and implies the following:

  • With the MRA turning fully operational, the authorities in both the EU and the US will now be able to rely on each other’s inspection results and can make the best use of their inspection capacities
  • The MRA yields greater efficiencies for the Regulatory systems in both territories, avoiding duplications in the inspections
  • It facilitates both territories to free up resources
  • As a biggest relief, with the MRA implemented, a batch-testing waiver will also come into force, which will be beneficial for products manufactured in the US and entering into EU market. In such cases, those products are not required to be batch tested as they have already gone through proper quality controls in the US

With the MRA headed for a positive implementation, both the territories, for sure can now look forward for easy market entry within the quickest possible time. But to do so, manufacturers should assure that their GMPs are on par with that of each side’s health authorities. Are your GMPs audited periodically and have they been assessed and properly validated? Evaluate now with a proven Regulatory expert.


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