Japan joins international GMP collaboration

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Japan joins international GMP collaboration

Home/Policies & Legislation | Posted 09/12/2016 0 Post your comment

The European Medicines Agency (EMA) announced on 25 November 2016 that it would be expanding its ongoing collaboration on good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturers to include Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The international collaboration allows manufacturers to share information on inspections of API makers located outside the participating countries. This can include sharing information on planning, as well as policy and reports.

The goal of the collaboration 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.

Other authorities already participating in the collaboration include EU Member States, the European Directorate of the Quality of Medicines and Healthcare (EDQM), the US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), Health Canada and the World Health Organization.

The initiative is in line with EMA’s and the Heads of Medicines Agencies’ strategy to 2020 for the European medicines regulatory framework, which aims to assure product supply chains and the best use of resources as priority areas where the network can make a difference to human and animal health.

EU lists Japan as having equivalent GMP standards

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Source: EMA