Europe Strengthens Collaborations with Japanese Pharmacopoeia

On Oct. 3, 2016, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced an enhanced collaboration between the directorate, the Pharmaceutical Safety and Environmental Health Bureau of the Ministry of Health, Labour and Welfare (MHLW), and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. The agencies will share information regarding GMP inspections of API manufacturing sites of interest to both Europe and Japan.

EDQM also signed a five-year Memorandum of Cooperation defining measures for strengthening collaboration between the European and Japanese pharmacopoeias, which include bilateral meetings, workshops, and internships between the two pharmacopoeias and various Japanese regulatory bodies. An ad hoc Technical Working Group on relevant topics was also agreed upon.

“This strengthened relationship will enhance the ability of the MHLW, PMDA, and EDQM to protect and promote the health and safety of the populations of their respective country/region. The constant aim of the partners will be to facilitate increased access to safe, effective, and high-quality products in Europe and Japan,” EDQM stated in a press release.