More FDA Inspections again - also in the EU?

The FDA has published its annual "State of Pharmaceutical Quality" report for fiscal year 2023, which aims to provide comprehensive insights into the quality of the U.S. drug supply chain. The report outlines key quality data, trends, and surveillance activities related to pharmaceutical manufacturing.

The report covers various aspects, including:

  • Quality surveillance programs and their effectiveness in monitoring the pharmaceutical market
  • Data on pharmaceutical manufacturers, their products, and instances of post-market quality defects
  • Information on import alerts, recalls, and Warning Letters issued to manufacturers
  • Emerging approaches to enhance pharmaceutical quality

Number of Inspections

The number of FDA-conducted drug quality assurance inspections, which includes surveillance and for-cause inspections, increased from 548 in FY2022 to 776 in FY2023; this is the highest number of inspections since the start of the COVID-19 Pandemic. In the same timeframe, the number of inspections classified under the MRAs increased from 144 in FY2022 to 187 in FY2023

This is also reflected in data published by Efpia (European Federation of Pharmaceutical Industries and Associations). The document "Annual Regulatory GMP/GDP Inspection Survey 2023 Data" is based on a survey of 26 global research-based pharmaceutical companies and two national trade associations. This may not sound like much, but it covers virtually all of these companies' sites. It also shows that the number of FDA inspections in the EU increased further in 2023 (see page 52 of the report). If the absolute number is broken down further, it becomes clear that the majority of these inspections (approx. ¾) would actually be covered by the MRA. The number of inspections by EU inspectorates is rather low in comparison.

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