Japan joins international collaboration on GMP inspections

In a further move to enhance quality, safety and efficacy of medicines globally, there was a positive move today with the news that Japan has now joined the effort.

The ongoing collaboration on good manufacturing practice (GMP) inspections of active-pharmaceutical-ingredient (API) manufacturers between the European Medicines Agency (EMA) and its international partners is to be expanded to include Japan’s Pharmaceutical and Medical Devices Agency (PMDA).

The international collaboration allows participants to share information on inspections, including planning, policy and reports, of manufacturers of APIs that are located outside the participating countries. The overall objective 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.