Japan - Proposed Shitei Yakubutsu(designated 6 substances), and their proper usesdesignated under the Act

Ministry of Health, Labour and Welfare (MHLW) has issued notification on "Shitei Yakubutsu" (designated substances), based on the provision of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as the "Act"). (1960, Law No.145)

Proposed date of adoption: 24 February 2017

Proposed date of entry into force: 6 March 2017

Final date for comments: Not applicable

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.