What happened
EMA’s report reviews the International API Inspection Programme from 2017 to 2024. Across 13 participating authorities, information was shared on 936 inspected sites and 1,684 inspections, approximately 50% more inspections than in the previous period. Of the sites, 644 (69%) were of shared interest; inspection reliance was reported for 107 sites. Authorities conducted 91 remote inspections, while 27 joint inspections covered 25 sites. Duplicate inspections affected 32% of sites and were more frequent following non-compliant outcomes. The report identifies legal, confidentiality, language, technical and resource barriers to report sharing and centralised data exchange. It recommends timelier information sharing, improved report usability, stronger reliance practices and action on duplication.
Why it matters
From a GMP manufacturing perspective, greater inspection reliance and coordination may reduce repetitive inspections and stakeholder burden while supporting broader oversight of API sites. Manufacturers with non-compliant outcomes may remain more likely to face additional inspections or re-inspections. The source’s focus on accessible reports, clear inspection scope, timely planning information and secure data exchange may matter because these elements support authorities’ ability to use other regulators’ inspection work.
Key topics: International API inspection reliance, Duplicate and joint GMP inspections, Cross-authority inspection data sharing
Source: European Medicines Agency (EMA)