At the 26th Cosmed Regulatory Congress in early April 2026, Haruhi Iwaki, a representative of the Japan Cosmetic Industry Association (JCIA), gave a presentation on the key concepts of Japanese cosmetics regulation, with a particular focus on the essentials for anyone wishing to export to Japan.
The regulatory framework
In Japan, the competent authority is the Ministry of Health, Labour and Welfare (MHLW), which is responsible for overseeing cosmetics, quasi-drugs, pharmaceuticals, food products, and medical devices.
The PMD Act
The main law is the “Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices” (PMD Act).
It regulates four categories of products: drugs (pharmaceuticals), quasi-drugs, cosmetics, and medical devices.
Japan does not have a law dedicated solely to cosmetics, which sets it apart somewhat from other regions. The system is unique in that it recognizes two categories of products: cosmetics (or general cosmetics) and quasi-drugs (or medicinal cosmetics).
Other reference materials
The regulatory framework also includes requirements for Good Manufacturing Practices (GMP), Good Quality Practices (GQP), and Good Vigilance Practices (GVP).
And two important laws regarding advertising: the Act against Unjustifiable Premiums and Misleading Representations and the Unfair Competition Prevention Act.
The Guidelines
The MHLW publishes technical guidelines regarding safety testing, alternatives to animal testing, impurities, and stability testing. Some of these guidelines were originally designed for the pharmaceutical industry, but they also apply to quasi-drugs.
The JCIA also develops voluntary guidelines, such as those regarding the sun …
