Ministry of Health, Labour and Welfare

Pharmaceuticals and Medical Devices

Policy Information

■ Outline of the Law for Partial Revision of the Pharmaceutical Affairs Law (Act No.84 of 2013) (PDF:1,072KB) 
■ Strategy of SAKIGAKE 
■ International Pharmaceutical Regulatory Harmonization Strategy – Regulatory Science Initiative – 
■ Registration opens for EMA/FDA/MHLW-PMDA Orphan Product Designation Workshop 
■ Overview of Orphan Drug/Medical Device Designation System 
■ Information for those who are bringing medicines for personal use into Japan  
■ 12th International Cooperation on Cosmetics Regulation (ICCR-12) Stakeholder Session on July 11, 2018 (PDF:30KB) 
■ Revision of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics  
■ Product Designation under the "SAKIGAKE Designation System" 
■ For the provisional translation of The Law on Securing Quality, Efficacy and Safety of Products, please visit here.
■ For information about PMDA, please visit here.

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