Agencies Agree to Expand GMP Sharing Between Europe, Japan

The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration.

The majority of the information shared will be the outcomes of GMP inspections of manufacturing sites for active pharmaceutical ingredients that are sold in both Europe and Japan.

The agencies include the Pharmaceutical Safety and Environmental Health Bureau of Japan’s Ministry of Health, Labor and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency of Japan, and the EDQM. All agencies have exchanged letters explaining how communication will be enhanced and how the information will be protected from the public domain.

Additionally, the EDQM and MHLW have signed a five-year Memorandum of Cooperation that defines concrete measures for strengthening collaboration between the European and Japanese authorities, including bilateral meetings, workshops and internships.

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