Japan implements a strict approval system of quasi-drug ingredients, which are mainly subject to the management of two kinds of lists as shown below: 1)Lists published by the MHLW, including Japanese Standards of Quasi-drug Ingredients 2006, Lists of Permitted Active Ingredients and List of Permitted Additives in Quasi-drugs. 2)Lists of patented quasi-drug ingredients of enterprises.
Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Japan legally classifies cosmetics into two categories: cosmetics and quasi-drugs. The most significant difference between quasi-drugs and cosmetics is whether they contain “active ingredients” that claim specific effects.
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