European Medicines Agency and United States Food and Drug Administration seek potential candidate companies for joint good-manufacturing-practice inspection programme
11/08/2010 - The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same medicinal product to both the EMA and the US FDA can request to participate in the pilot programme for joint pre-approval inspection should such an inspection be considered necessary by both agencies.
The overall objective is to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication.
Companies can also participate in the pilot exercise by hosting a single join re-inspection (routine surveillance) where both the EMA and the US FDA have separately planned routine surveillance inspections (re-inspections) to take place within a similar time period at a manufacturing site of a medicinal product authorised in the USA and centrally authorised in the European Union.
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- European Medicines Agency / Food and Drug Administration joint good-manufacturing-practice-inspection pilot programme - General principles (15/11/2010)
- European Medicines Agency / Food and Drug Administration joint good-manufacturing-practice-inspection pilot programme - Terms of reference and procedures for participating authorities (manufacturers of medicinal products) (15/11/2010)