No more FDA Inspections in the EU - really?

All EU member states are now part of the MRA (Mutual Recognition Agreement). The FDA was already recognised by the EU in 2017. The main objective was to mutually accept the respective GMP inspection systems and to reduce the number of foreign inspections.

But the FDA will continue to travel to the EU for inspections. In the current EMA Questions & Answers document (EMA/395913/2019) it is said, that it is (only) "expected that the FDA will not duplicate inspections conducted by a recognised authority". Both the EU and FDA will still have "the right to inspect in each other's territory at any time".

What about pre-approval inspections?

So called "application-specific inspections", such as FDA's pre-approval and post-approval inspections, are within the scope of the MRA. However in its Frequently Asked Questions document from July 2017, the FDA points out that "these inspections are based upon the application submitted to a specific human drug regulatory authority" and that "additional coordination and assessments are required". On the frequently updated website it seems the FDA intends to keep all options open: "FDA will continue to perform some inspections …, such as product manufacturing assessment inspections to support marketing approval decisions". At least, the authority "expects to perform fewer routine surveillance inspections in EU".

This also became clear at an ECA conference in November 2018, where participants from Spain, Austria and Denmark - countries which were already accepted and part of the MRA at that time - reported on announced inspections for the year 2019.

And there are still some products excluded from the scope of the MRA.

  • Veterinary products (probably until December 2019)
  • Vaccines and plasma-derived products (probably until July 2022)
  • Human blood, plasma, tissues and organs
  • Veterinary immunologicals

Here, inspections may be performed any time.

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