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New agreement between EU and Japan for sharing more information on GMP inspections

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan.

Both regulators began sharing such inspection data back in 2013, though mutual recognition agreements which dates back to 2003. And back in 2012, the European Fine Chemical Group, an industry association of API manufacturers, called for mandatory inspections of all API manufacturing sites through the use of mutual recognition agreements.

The EU and US, meanwhile, are still working on ways they can mutually recognize each other’s GMP inspections. A major issue for the sharing of any nonpublic information is the question of trade secret information (inspections typically involve specifications of manufacturing equipment and processes for manufacturing drugs that are proprietary information), though there is a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA) from 2012 to allow FDA to share trade secrets with other regulators.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) and MHLW (Ministry of health, labor and welfare) have signed a 5-year memorandum of cooperation defining measures to strengthen the collaboration between the European and Japanese pharmacopoeias. These include the option of organizing bilateral meetings, workshops and internships between the two and various Japanese regulatory bodies in order to share experiences and information on the development of monographs and methods of testing.



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