Manufacturers Sought for Joint FDA-EMA GMP Inspection Pilot

The European Medicines Agency (EMA) is seeking drugmakers to participate in a joint EMA-FDA GMP inspection pilot program.

Eligible manufacturers must have submitted in parallel to the FDA and EU national authorities (coordinated by the EMA) two equivalent premarket applications for the same drug, the EMA said last month. Companies due for a routine surveillance by both agencies also can participate by agreeing to host a single joint reinspection.

So far, two sites have been inspected. The objective is to conduct about five joint inspections by the end of the year, David Cockburn, head of manufacturing and quality compliance at the EMA, said.
Drug GMP Report