The document is the enforcement regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Note: This translation was published by Japanese Law Translation and is an unofficial text. The translation is only updated to the 2015 revision while the revised edition of 2016 is in effect. This document should only be used as a reference for understanding Japanese regulations and in case of any discrepancy between the English and Japanese versions the original Japanese version shall prevail.
Chapter I Pharmacy (Articles 1 to 18)
Chapter II Marketing and Manufacturing Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics (Articles 19 to 114)
Chapter III Marketing and Manufacturing Medical Devices and In-Vitro Diagnostics
Chapter IV Marketing and Manufacturing Regenerative Medicine Products (Articles 137-2 to 137-78)
Chapter V Selling Pharmaceuticals, Medical Devices and Regenerative Medicine Products (Articles 138 to 196-13)
Chapter VI Official Verification of Pharmaceuticals (Articles 197 to 203)
Chapter VII Handling of Pharmaceuticals (Articles 204 to 228-9)
Chapter VIII Advertisement of Pharmaceuticals (Article 228-10)
Chapter IX Safety Measures for Pharmaceuticals (Articles 228-11 to 228-27)
Chapter X Special Provisions Concerning Biological Products (Articles 229 to 243)
Chapter XI Supervision (Articles 244 to 249)
Chapter XII Handling of Designated Substances (Articles 249-2 to 249-8)
Chapter XIII Designation of Orphan Drugs, Orphan Medical Devices, and Orphan Regenerative Medicine Products (Articles 250 to 252)
Chapter XIV Miscellaneous Provisions (Articles 253 to 288)
Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
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