May 2018: Japan Regulatory Updates

An HBD workgroup compared Japanese regulations, U.S. FDA regulations, existing international standards, and guidelines related to good clinical practices, and found no major differences in the fundamental criteria for ethical clinical research. HBD published the results of the study in April 2010. The results were considered in the 2011 revision of the ISO 14155 standard entitled, “Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practices.” In 2013, HBD published an updated study showing that one clinical investigation design accepted by multiple regulatory authorities improves acceptance of clinical investigation data, and can meet regulatory requirements for marketing approval. These studies were published in the Regulatory Affairs Professionals Society Regulatory Focus journal, and by the Japanese Federation of Medical Devices Association.

HBD and the University of Tokyo conducted a survey asking several Japan, U.S., and E.U. based-medical device manufacturers about the costs of medical device clinical trials. This helped uncover common challenges in bringing innovative and safe device technologies to patients.

A person wishing to manufacture drugs, quasi-drugs or cosmetics exported to Japan from overseas (overseas manufacturers) must receive accreditation from the Minister. The specifications for accreditation are the same as those for manufacturing licenses for domestic manufacturers. A person intending to start manufacturing regenerative medicine products to be exported to Japan in a foreign country must also obtain accreditation of an overseas manufacturer of regenerative medicine products.

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