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News on Worldwide Cosmetics Regulations - Focus Japan, China, Taiwan, Hongkong

Jun 16, 2010

Japan: Quasi-drugs are defined in Japan as products with restricted use while having a mild action on the human body1. The category includes hair tonics, bath preparations, skin whitening products, leave-on acne products anti-dandruff shampoos, fluorinated toothpastes, hair dyes, etc. They are borderline products which are categorized differently in various markets; therefore, the applicable regulatory framework has to be carefully researched.Manufacturers of quasi drugs need to be accredited by the Minister of Health, Labour and Welfare (MHLW)2 according to Article 13-3 of the Japanese Pharmaceutical Affairs Law (PAL). This applies to domestic manufacturers as well as to foreign manufacturers when importing products into Japan. Additionally a premarketing approval of the Pharmaceutical and Food Safety Bureau of the MHLW applies according to Article 14 of the PAL. For the application of the marketing approval a foreign manufacturer must appoint a drug marketing authorization holder in Japan who performs all procedures with the MHLW on behalf of the applicant. The marketing authorization holder can as well apply for the manufacturing license of the manufacturer and is also authorized to market the products. All paperwork for the applications needs to be submitted in Japanese language. The regulatory agency conducting the scientific reviews for the marketing approval is the Pharmaceuticals and Medical Devices Agency (PMDA)3 which also monitors the postmarketing safety. Recently this agency also provided many regulatory texts and application forms in English translations on its website. However, it is reminded that the English documents are only for reference purposes; in case of any discrepancy, the Japanese text will prevail...

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