The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are seeking potential candidate companies for a joint GMP inspection pilot program. The overall goal of the program is to see whether greater international collaboration can help distribute inspection capacity, allowing more manufacturing sites to be monitored.
Companies that have submitted in parallel two equivalent marketing authorization applications for the same medicinal product to both regulatory bodies can contact the FDA or EMA to participate in a joint pre-approval inspection if such an inspection is considered necessary by both the agencies.
Following a joint inspection, each participating authority is responsible for any follow-up actions within their territory based on the commonly agreed outcome. If a major disagreement occurs, both regulatory bodies should proceed separately and follow their own procedures.
Companies also can participate in the pilot exercise by hosting a single join re-inspection (routine surveillance) where both the EMA and the 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 authorized in the US and centrally authorized in the European Union.
The document with terms of reference and procedures for participating authorities is available on EMA’s web site.