Regulatory systems Japan

B.J. Meacham, Concepts of a Performance-Based Building Regulatory System for the United States , Fftth Interruitional Symposium, pp. 701-712, International Associatirm fm Fire Safety Science, edited by Y. Hasemi, Japan, 1997. 

As described in Section 1.1, three main regulatory systems exist at a global level in the domain of cosmetics those of the European Union (EU), the United States (US) and Japan. These regulatory models have been used by many other countries or conununities... 

These products are classified into different categories by different countries, which depend on the legislation in force in each country. As mentioned in Section 1.1, the three main regulatory systems on cosmetic products are the European Union (EU) Cosmetics Directive, the United States (US) Food and Drug Administration (FDA) rules and the Japanese legislation. Both EU and Japan consider sunscreen products as cosmetics, whereas the US considers them as over-the-counter (OTC) drugs (see further on). 

Jellinek, S. D. Paper presented at Fuji Techno Systems Seminar on the Impact of Regulatory Requirements on Chemical Substances, Tokyo, Japan, Oct. 30, 1980, cited in U.S. Office of Technology Assessment, "Assessment of Technologies for Determining Cancer Risks from the Environment " 1981, p. 148. 

The Pharmaceuticals and Cosmetics Division (Koseisho) of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare (MHW) is the regulatory body in Japan. Also in Japan there have been clear changes in the drug approval system, mainly inspired by ICH. One of the most important recent changes is that, under certain conditions, it is now possible to use also foreign data for the approval of new dmgs in Japan. 

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