Why does the FDA inspect in EU despite the MRA?

The main objective of the MRA (Mutual Recognition Agreement) between the EU and the FDA established in 2019 was to mutually recognise GMP inspection systems and reduce the number of inspections. However, this does not mean that there are no more mutual inspections at all. This is not only due to the exceptions laid down in the original document (human blood, human plasma, human tissue and organs, and immunological veterinary medicinal products), but also because of a certain degree of discretion. For example, Chapter 3 (Operational Aspects), Article 8 (Acceptance of Inspections), paragraph 2, states: "A Party may in specific circumstances opt not to accept an official GMPs document issued by a recognized authority of the other Party for manufacturing facilities located in the territory of the issuing authority." Examples include:

  • Indications of material inconsistencies or deficiencies in the inspection report
  • Quality deficiencies identified during post-market surveillance
  • Specific indications of serious concerns about product quality or consumer safety

The EMA Questions & Answers document (EMA/395913/2019) states that it is expected (only) that the FDA will not duplicate inspections. Both the EU and the FDA still have (exceptionally) "the right to inspect in each other's territory at any time".

What about pre-approval inspections (PAI)?

This is not quite clearly defined. Pre-approval inspections are neither clearly included nor excluded. According to Article 4 (Products covered), the Agreement applies primarily to "marketed finished pharmaceuticals for human or animal use" and according to Article 3 (Scope) to "post-approval inspections"; here, however, with a possibility for "requests for pre-approval inspections" as specified in Article 11.

Here, the Q&A documents and a working report are helpful:
The corresponding Q&A document of the FDA states that "As of July 2019, both the FDA and European Union have been actively engaged in evaluating how best to implement the US-EU MRA for consideration of pre-approval inspections (PAIs). This evaluation is ongoing and in December 2019 both FDA and European Union agreed and have been engaged in jointly developing a PAI capability assessment workplan for mutual recognition of and reliance on each other's expertise for PAI coverage of manufacturing facilities (…). However, the work planned and under way is encountering unavoidable delays due to both increased regulator workload and restrictions on activities on both EU and FDA staff (…)."
And the annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021 succinctly states "Work on the inclusion of pre-approval inspections was put on-hold".

Since then, not much has happened here.

What does this mean in concrete implementation?

A very good source is the FDA Data Dashboard. This detailed overview of FDA activities carried out offers easy-to-use and understandable tables and graphs for comprehensive analysis.

According to the dashboard, ten inspections in the area of "Drugs" were completed at German companies in 2021 alone - and that despite the pandemic and MRA. And pre-approval inspections are not even listed here. In the previous year (2020), there were 27, in 2019 68, and 36 in 2022. If all EU member states are selected, one arrives at the impressive number of 169 in the fiscal year 2022 (117 in the previous year).

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