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
- 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.
Recent Press Releases
To protect people from drug abuse
- For Travelers
- Illicit Drugs[PDF:748KB]
- Cannabis[PDF:902KB]
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