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. Overview of Quasi-drugs in Japan

• Definition
• Classification
• Competent authorities

2. Regulatory Requirement of Controlled Ingredients

• Active ingredients
• Additives

3. Regulatory Requirement and Process of Importation

• Manufacturing and sales approval for quasi-drugs
• Documents and necessary procedures
• Accreditation of Foreign Manufacturers
• GMP
• Labeling requirements

Who Should Attend

• Cosmetic companies whose target market is Cambodia, Laos, and Myanmar or ASEAN countries; or
• Companies who are interested in Cambodia, Laos, and Myanmar or ASEAN cosmetic regulations; or
• Cosmetic companies who want to increase competitiveness level and win Cambodia, Laos, and Myanmar consumers.

Schedule