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Japan joins int'l collaboration on GMP inspections: EMA

Xinhua, November 26, 2016 Adjust font size:

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 will be expanded to include Japan's Pharmaceutical and Medical Devices Agency (PMDA), the EMA said Friday.

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, according to an EMA statement.

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.

As part of this initiative, PMDA joins efforts from authorities in Europe, including EMA, EU member states and the European Directorate of the Quality of Medicines and Healthcare (EDQM). Endit