Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145); (1 page(s), in English)

Draft Commission Delegated Regulation supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down the procedure regarding inclusion in or removal from the European positive lists of starting substances, compositions and constituents; (11 page(s), in English), (2 page(s), in English)

Regulations governing licensing of public and private manufacturers, distributors, wholesalers and retailers of medical Products; (13 page(s), in English)