Active pharmaceutical ingredients: Japan joins international collaboration on GMP inspections

News 25/11/2016

Increased cooperation to enhance quality, safety and efficacy of medicines globally

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.

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), as well as the United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), Health Canada and the World Health Organization.

The initiative aligns with EMA's and the Heads of Medicines Agencies' (HMA) strategy to 2020 for the European medicines regulatory network. The strategy highlights assuring product supply chains and ensuring best use of resources as priority areas where the network can make a difference to human and animal health.

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