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In September, Japanese regulatory agencies and EDQM announced a 5-year “Memorandum of Cooperation” that defines concrete measures for strengthening collaboration between the European and Japanese Pharmacopoeias. It calls for sharing of information on the outcome of GMP inspections of manufacturing sites of active pharmaceutical ingredients of interest to both Europe and Japan, and includes the option of organizing bilateral meetings, workshops, and internships between them and an ad hoc Technical Working Group involving staff members of the EDQM and Japanese regulatory bodies as well as relevant experts.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
