Japan Cosmetics and Quasi-Drug Compliance

Background of Cosmetic Regulations in Japan

Japan is a major player in the cosmetics and personal care industry, with a market that values high-quality innovative, and safe products. In Japan, cosmetics are regulated by the Pharmaceutical and Medical Device Act, which sets compliance requirements and defines two types of products: cosmetics and quasi-drugs. The Ministry of Health, Labour, and Welfare (MHLW) is the main entity that regulates cosmetic products made available on the Japanese market. It is responsible for approving quasi-drug applications, receiving cosmetic notifications, monitoring adverse reaction reports, and inspecting company premises.

Although the compliance application process for cosmetics and quasi-drugs is similar, the requirements for quasi-drugs and their importers are more stringent. Importers are responsible for quality assurance and product liability and must acquire a specific license and be appointed as drug marketing authorization holders (MAH). In addition, importers of imported and distributed cosmetics must obtain a cosmetics production and sales license and a cosmetics manufacturer license, and submit corresponding notifications to the appropriate administrative agency before starting product imports.

About Us

As a company that specializes in regulatory compliance for the cosmetics and personal care industry, we offer a range of services to help companies achieve compliance with the MHLW regulations.

Our team of compliance experts provides guidance and technical support for the regulatory requirements of cosmetics and quasi-drugs sold in Japan. We assist with preparing product information files, safety assessment reports, and other necessary notifications to the MHLW. We can also provide support in interpreting and complying with the various regulations set forth by the MHLW. Our expertise in regulatory compliance can help companies navigate the complex regulatory landscape in Japan and ensure their products meet the necessary safety and efficacy standards, allowing them to successfully market their products to Japanese consumers.

Cosmetics Vs. Quasi-Drugs

Our Japanese cosmetic compliance services cover cosmetics and quasi-drugs.

Our Japan Cosmetics and Quasi-Drug Compliance Services

Our company provides Japanese cosmetic compliance services to Japanese cosmetic importers/major distributors as well as cosmetic manufacturers or distributors exporting cosmetic products to Japan. Our services include:

Formula & Label & Claims Review

• Provide a determination of the product category (cosmetic or quasi-drug)
• Provide INCI and ingredients lists in Japanese, as well as usage warnings and precautions
• Provide toxicological and regulatory assessments of ingredients
• Provide formula review report, including ingredients names, ingredient percentage, safety margins, and experts' comments
• Provide label and claims review report, including required elements, presence of required elements, conclusions on each claim, final ingredients list in Japanese, and experts' comments

Cosmetic Notification Dossier Preparation

• Assist a company in obtaining a cosmetics manufacturing and sales license and a cosmetic manufacturer's license
• Submit the Manufacture and Sales of Cosmetics Notification
• Submit the Cosmetics Import Notification for Manufacture and Sales

Pre-Approval Dossier Preparation for Quasi-Drugs

• Evaluation of the documentation needed for pre-approval (Data regarding physical and chemical properties, testing methods, stability, safety, efficacy, etc.)
• Determine the data required for registration based on the category of quasi-drugs

If you need help or have a question, please feel free to contact us for more details.