1. Authorities

Cosmetics
Japan

This section provides an overview of the Authorities involved in setting regulations and managing compliance with the Cosmetics product in scope.

Ministry of Health, Labour and Welfare (MHLW)

In Japan, the Ministry of Health, Labour, and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law regulates cosmetics. A series of subsidiary rules, standards, and guidance documents issued by the Ministry of Health, Labour, and Welfare (MHLW) support cosmetics.

MHLW acts on securing the quality, efficacy, and safety of products including pharmaceuticals and medical devices by enforcement of the "Act for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical and Medical Devices" (Shortly Pharmaceutical and Medical Devices Law).

The MHLW may have the Pharmaceuticals and Medical Devices Agency (PMDA) conduct an inspection of cosmetics to evaluate the adverse effect reports and review the applications of foreign manufacturers and importers.

1.1 References

1. Ministry of Health, Labour, and Welfare of Japan

https://www.mhlw.go.jp/english/

2. Japanese Law Translation

https://www.japaneselawtranslation.go.jp/ja/laws/view/3213 

3. Pharmaceuticals and Medical Device Agency

https://www.pmda.go.jp/english/