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