Law No. 145 on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices.

This Law, consisting of 91 articles divided into seventeen Chapters, establishes Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices. It aims to secure the quality, efficacy and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, regenerative medicine products (pharmaceuticals), to provide the control required for preventing the occurrence or spread of hazards to public health and hygiene caused by the use of such pharmaceuticals, to take measures against designated substances, and to improve public health and hygiene by taking necessary measures for the promotion of research and development of pharmaceuticals, medical devices and regenerative medicine products which are especially important for medical practice. In order to achieve the purpose of this Law, the national government shall develop and implement measures required to secure the quality, efficacy and safety of pharmaceuticals, to prevent the occurrence or spread of hazards to public health and hygiene caused by the use of these pharmaceuticals, and other necessary measures.
The Law is divided as follows: General Provisions (Chapter I ); Prefectural Pharmaceutical Affairs Councils (Chapter II); Pharmacies (Chapter III); Marketing and Manufacturing of Pharmaceuticals, Quasi-drugs and Cosmetics (Chapter IV); Marketing and Manufacturing Businesses Concerning Medical devices and In-vitro Diagnostics (Chapter V); Marketing and Manufacturing for regenerative medicine products (Chapter VI); Marketing of Medical devices and regenerative medicine products (Chapter VII); Standards and Official Assay of Pharmaceuticals and Medical Devices (Chapter VIII); Handling of pharmaceuticals and Medical devices (Chapter IX); Advertisement of pharmaceuticals ( Chapter X); Safety Measures for Pharmaceuticals (Chapter XI); Exceptions to Biological Products (Chapter XII); Supervision (Chapter XIII); Handling of Designated Substances (Chapter XIV); Designation of Orphan Pharmaceuticals, Orphan Medical Devices and Orphan Regenerative Medicine Product (Chapter XV); Miscellaneous Provisions (Chapter XVI); Penalties (Chapter XVII).