EMA Extends Collaboration Efforts to Japan on GMP Inspections

The ongoing collaboration on GMP inspections of API manufacturers between the EMA and its international partners will be expanded to include Japan’s Pharmaceutical and Medical Devices Agency (PMDA).

The international collaboration allows manufacturers to share information on inspections of API makers located outside the participating countries.

The goal is to increase cooperation and mutual reliance between regulators participating in the initiative, as well as to ensure the best use of inspection resources worldwide.