Japan

Policy

The Pharmaceutical Affairs Law includes regulations on botanical medicines and on TM/CAM practices.  While these laws have been in effect for several decades, presently there is no national policy stated.   Research into TM/CAM is carried out by the National Institute of Health Sciences.

Contact

Ministry of Health, Labor and Welfare                   

Website: http://www.mhlw.go.jp/english/index.html

 

Laws & Regulations

The Japanese Ministry of Health Labor and Welfare created Foods for Specified Health Use (FOSHU) in 1991.  FOSHU allows manufacturers and marketers to make qualified health claims on foods.  Japan is credited with creating the term "Functional Food" and has been able to assign a direct definition to the term unlike most other nations that allow functional foods in the marketplace.  FOSHU products are intended to reduce disease and promote health and well-being. No disease related claims may be made on nutritional products.

The Japanese pharmacopoeia is used and is considered to be legally binding.  Manufacturing of botanical products deemed to be medicines must follow the same GMP procedures and those for conventional drugs.

There has been a post-marketing surveillance system in place for several years.

The Pharmaceutical Affairs Law includes regulations on botanical medicines and on TM/CAM practices. All practices, treatment and quality of medicines of Japanese TM/CAM are controlled by the Medicine Law and the Pharmaceutical Affairs Law.

 

Contact

Ministry of Health, Labor and Welfare                   

http://www.mhlw.go.jp/english/index.html