EFPIA: Results of the Member Survey 2025 on GMP and GDP Inspections
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published the results of its “Annual Regulatory GMP/GDP Inspection Survey 2025”. The data suggest that international GMP inspections are increasingly being replaced by reliance and work-sharing approaches between inspectorates.
According to EFPIA, the number of reported inspections decreased by approximately 25% compared with the 2015–2019 period. The industry interprets this as a possible indication that authorities are increasingly relying on inspections performed by other inspectorates and reducing duplication.
The survey particularly highlights that:
- foreign inspections are decreasing overall,
- reliance approaches among PIC/S authorities are advancing,
- on-site inspections remain the standard,
- remote inspections are only a backup option,
- document-only inspections are declining significantly,
- inspections are becoming more risk-based and system-focused.
EFPIA also reports that implementation of the revised Annex 1 has not led to an increase in inspections at sterile manufacturing sites. In addition, announced and unannounced inspections reportedly showed similar outcomes.
Further trends identified in the survey include:
- stronger inter-agency coordination,
- coordinated or joint inspections,
- harmonised inspection report formats,
- and digital collaboration platforms for information exchange between authorities.
EFPIA calls on authorities to make broader use of existing reliance tools, particularly PIC/S mechanisms and Mutual Recognition Agreements (MRAs), and to further pursue the vision of “one inspection per site”.
Source:
EFPIA: Annual Regulatory GMP/GDP Inspection Survey 2025 data
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