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Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

  •   4 Dec 2018
  •    Winnie Xu
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    Japan
    • Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

    • Language:EN
    • Format:Electronic Edition (Adobe PDF)
    • Pages:311
    • Translated by: Japanese Law Translation
    • Publish date: 2018-11-21
    • Price: Free

    Details

    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.

    Contents

    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)
    Supplementary  Provisions