Biovian obtained Accreditation Certificate of Foreign Drug Manufacturer from the Japanese Pharmaceuticals and Medical Devices Agency.
We are pleased to announce that Biovian has obtained the Accreditation Certificate of Foreign Drug Manufacturer from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Application category is Biological Products and Number of Accreditation AG22200020.
What is Accreditation of Foreign Manufacturers?
A foreign manufacturer intending to manufacture drugs, quasi-drugs, or medical devices in foreign countries and export them to Japan, is required to be accredited by the Minister of Health, Labour, and Welfare as an “Accredited Foreign Manufacturer”, specified in Article 13-3 of PAL, in the same way, that a Japanese manufacturer is licensed.
Accreditation of Foreign Manufacturers | Pharmaceuticals and Medical Devices Agency (pmda.go.jp)