A foreign manufacturer intending to manufacture quasi-drugs in foreign countries and export them to Japan is required to be accredited by the MHLW as an “Accredited Foreign Manufacturer”.
On April 28, 2021, MHLW updated the Instructions for Accreditation of Foreign Pharmaceuticals/Quasi-drug Manufacturers (hereafter referred to as "the Instructions"), which mainly deals with prompt accreditation approval.
This Instructions came into force upon issuance, and the original Instructions which was implemented on Oct. 8, 2010 became invalid automatically.
Original regulatory document
