Frequently Asked Questions - Cosmetic Regulations in Japan

Updated: Jan 7



1. Who regulates cosmetics in Japan?

In Japan, cosmetics are regulated by the Ministry of Health, Labour and Welfare. This authority is responsible for formulating and implementation of regulations related to cosmetics.


2. What are Quasi drugs in Japan?

Products in Japan are categorized as either cosmetics or Quasi-drugs. These are the products somewhere in between cosmetics and pharmaceuticals. These drugs are labeled as such even if they appear to be essentially cosmetics.


3. How to import cosmetics to Japan?

To import cosmetics to Japan,

  • Ensure that the products are in accordance with Law.

  • Get the samples assessed according to the MHLW.

  • Submit all the forms required and handle the clearance.

  • Obtain cosmetic marketing notification.


4. What is the process to register cosmetics in Japan?

To register a cosmetic product in Japan,

  • Complete Ingredient Analysis.

  • Assign a responsible agent in Japan.

  • Procure Marketing notification.

  • Market cosmetics.


5. Who sets standards for cosmetic products in Japan?

In Japan, cosmetics are under the control of Ministry of Health, Labour and Welfare (MHLW). It is the competent authority regulating cosmetics and formulating drug regulations and standards.


6. What is GVP?

As a part of the Good Quality Practices, marketing license holders are required to properly evaluate their production management and quality control of cosmetics to be marketed. Marketing license holders must establish systems that are capable of providing and retaining accurate information in response to consumer inquiries along with a monitoring system that handles customer complaints on product quality and product recalls, as required by the GVP standards.


7. What is GMP Inspection?

GMP compliance certificate is issued by the authorities after thorough inspection of the manufacturing sites. The compliance is issued only if all the requirements are met by the manufacturer.