Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (also known as Pharmaceutical and Medical Devices Law) is the overarching act that regulates the manufacture, importation, and sale of drugs, quasi-drugs, cosmetics and medical devices in Japan.
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 General Provisions (Articles 1 to 2)
Chapter II Prefectural Pharmaceutical Affairs Councils (Article 3)
Chapter III Pharmacies (Articles 4 to 11)
Chapter IV Marketing and Manufacturing of Pharmaceuticals, Quasi-Pharmaceutical Products and Cosmetics (Articles 12 to 23)
Chapter V Marketing and Manufacturing Businesses for Medical Devices and In-vitro Diagnostics
Chapter VI Marketing and Manufacturing of Regenerative Medicine Products (Articles 23-20 to 23-42)
Chapter VII Selling of Pharmaceuticals, Medical Devices and Regenerative Medicine Products
Chapter VIII Standards and Official Verification of Pharmaceuticals, etc. (Articles 41 to 43)
Chapter IX Handling of Pharmaceuticals, etc.
Chapter X Advertisement of Pharmaceuticals, etc. (Articles 66 to 68)
Chapter XI Safety Measures for Pharmaceuticals, etc. (Articles 68-2 to 68-15)
Chapter XII Exceptions of Biological Products (Articles 68-16 to 68-25)
Chapter XIII Supervision (Articles 69 to 76-3)
Chapter XIV Handling of Designated Substances (Articles 76-4 to 77)
Chapter XV Designation of Orphan Drugs, Orphan Medical Devices and Orphan Regenerative Medicine Products, etc. (Articles 77-2 to 77-7)
Chapter XVI Miscellaneous Provisions (Articles 78 to 83-5)
Chapter XVII Penalties (Articles 83-6 to 91)