Japan's MHLW Publishes New Quality Standards for Quasi-Drugs


On October 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) has published new quality standards and specifications of 2,647 ingredients and additives that can used in Quasi-drugs.


In Japan, cosmetic products are regulated by the Pharmaceutical and Medical Device Act, which stipulates compliance requirements and defines two categories of products: cosmetics and quasi-drugs. Quasi-drugs are in between pharmaceuticals and cosmetics, having officially recognized active ingredients.

The new requirement stipulates that companies should comply with the registration requirements and obtain MHLW approval before using the listed ingredients in their products. Companies have until 30 September next year to comply.

Amendment of Standards for Quasi-drug: Ingredients Japanese Standards of Quasi-drug Ingredients (JSQI 2021) includes:

  • Combines the original two attached active ingredient lists into one list, and sorts them according to the kana syllabary;
  • Modifies the specifications of 1453 ingredients;
  • Deletion of the listing of “ethanol” ingredient, and replacement by ‘dehydrated ethanol’ and ‘denatured alcohol’.
  • Addition of two general test methods which brings the total number of test methods to 84
  • Revision of 17 test methods

Note: After deleting Ethanol (96), “Ethanol” specified in JSQI 2021 only refers to “dehydrated ethanol” and “denatured alcohol”.

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GRP is global consulting and market Access firm Headquartered in Boston Massachusetts USA. GRP- Japan office located in Tokyo provides Local Representation services (MAH), Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product.

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Japan Regulations for Cosmetic

Check out GRP Regulatory Intelligence platform for Cosmetic Regulations released by the MHLW and PMDA. Regulations have been formatted and translated to English for easy understanding and access. Now on Sale!

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico & Korea. 

GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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