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Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
Local Title:
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律
Country/Region:
Japan
Competent Authority:
Ministry of Health, Labour and Welfare
Type:
Regulation
Status:
In force
Release Date:
2022-06-17
Implementation Date:
2022-06-17
Document
Language Source Title Access
JA
Official Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
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Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
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Summary

The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (short for "Pharmaceutical and Medical Devices Law") is the overarching act that regulating the manufacturing, importation, supervision, and sale of pharmaceuticals, quasi-drugs, cosmetics, medical devices and regenerative medicine products. 

This regulation applies to the quality, efficacy and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices and regenerative medicine products, preventing the occurrence or spread of hazards in health and hygiene caused by the use of these.

History
2022-06-17
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
In force
Release Date: 2022-06-17
Implementation Date : 2022-06-17
2019-06-14
Invalid
Release Date: 2019-06-14
Implementation Date : 2019-09-14
2018-07-06
Invalid
Release Date: 2018-07-06
Implementation Date : 2018-07-06
2015-06-26