Cosmetic Compliance
Intelligence & Solutions

Decoding the Regulations of Quasi-drugs in Japan

$ 99 premium members free
Rose Hong
Thursday , 16th Dec 2021

According to Japan’s Pharmaceuticals and Medical Devices Act (the “Act”), cosmetics are classified into two categories: cosmetics and quasi-drugs. Quasi-drugs are a product category unique to Japan, which falls in between pharmaceuticals and cosmetics. They contain a certain concentration of active ingredients approved by the Ministry of Health, Labour and Welfare and have higher efficacy. Common examples include deodorants, depilatories, hair dyes, hair perms, and medicated cosmetics (whitening, anti-acne, anti-aging products, etc.).

In recent years, the Japanese quasi-drug market has been continuously expanding, driven by increased environmental pollution and rising awareness for oral and personal hygiene. Foreign enterprises accordingly show interest in the lucrative market. However, many of them have difficulty accessing to the market due to Japan’s unique and complicated administrative rules and language barriers.

This webinar aims to shed light on the regulatory requirements of quasi-drugs in Japan. In the webinar, Ms. Rose Hong, the regulatory analyst from ChemLinked, will introduce the definition, classification, regulated ingredient requirement, import procedures, etc. of quasi-drugs, offering a preliminary overview for companies wishing to export products to Japan.


1. Regulatory Background of Quasi-drugs in Japan

  • Definition & classification

  • Quasi-drugs v.s. cosmetics

  • Competent authorities

2. Controlled Ingredients of Quasi-drugs

  • Active ingredients

  • Additives

  • New ingredient application

3. Import Procedures and Requirements

  • Manufacturing and sales approval for quasi-drugs

  • Documents and necessary procedures

  • Accreditation of Foreign Manufacturers

  • GMP

  • Labeling requirements

4. Post-market Supervision

*The final outline may be subject to subtle revision.

Contact Information

If you have any questions about this webinar, please contact us at:


TEL: +86 (0) 571 8609 4444

  • ChemLinked Regulatory Analyst
    Rose Hong is an analyst in ChemLinked and focusing on track, research and analysis on laws and regulations on the Food and Cosmetics of Japan. She has published several news and news tickers, especially in those sectors: food safety, food additives, beverages, FCM, and food labeling.