Japan implements a three-tier regulatory system with clearly defined division of responsibilities:
Ministry of Health, Labour and Welfare (MHLW): The competent authority for the cosmetics industry, responsible for formulating regulations and standards, as well as making final approval decisions.
Pharmaceuticals and Medical Devices Agency (PMDA): Responsible for document review and on-site inspection of applications from foreign manufacturers and importers, as well as assessment of adverse reaction reports.
Prefectural Governments: Responsible for business licensing, routine inspection and guidance for local enterprises.
Official Website of the Regulatory Authority: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/keshouhin/
Pharmaceutical and Medical Device Law (PMDL), formerly known as the Pharmaceutical Affairs Law (PAL)
1.Definition of General Cosmetics
Cosmetics are defined as substances intended to be applied to the human body by rubbing, spraying or other similar methods, for the purposes of cleansing, beautifying, enhancing attractiveness, improving appearance, or maintaining the health of the skin and hair. Pharmaceuticals and quasi-drugs are excluded from this category.
2.Special Category: Quasi-drugs
Products with specific efficacies, such as deodorants, hair removers, hair growth treatments, bactericidal disinfectants and whitening products, are classified as quasi-drugs and regulated by the PMDA, with stricter market access requirements.
Detailed information of a Japanese importer holding a valid Cosmetic Manufacturing and Marketing License.
Power of Attorney issued by the overseas manufacturer.
Documentation related to the cosmetic quality management system and post-marketing safety management system.
Complete qualification information of the overseas manufacturer.
Basic product information, efficacy claims, full ingredient formulation list and compliant labels.
Japanese
Notification Form
Full ingredient list (using Japanese INCI nomenclature)
Test/inspection records confirming that the product does not contain prohibited ingredient combinations (or supplier’s full ingredient certification)
Manufacturer/importer information (company name, address, contact information)
Basic product information (name, formulation, manufacturing method, specification, instructions for use, shelf life, etc.)
Draft label (must be in Japanese, with full ingredient declaration)
1.Registration Procedure
Precondition: Foreign Manufacturer Certification (Mandatory)
Certification procedure: The foreign manufacturer submits an application → Application is submitted to the Minister of MHLW → PMDA conducts document review (required in principle) and on-site inspection → Inquiry and response with the Compliance Office → Review results are notified to MHLW → Ministerial approval → Foreign Manufacturer Recognition Certificate is issued.
Overall product access procedure: Product classification and definition → Importer qualification verification → Ingredient and label compliance review → Completion of foreign manufacturer certification → Submission of product information notification.
2.Official Fees (Unit: JPY)
For general cosmetics: No PMDA review and approval is required, and there is no official fee.
Cosmetic products in Japan are not subject to pre-market approval. They only need to comply with the Standards for Cosmetics and complete the notification/filing formalities before marketing.
All fees specified below are denominated in Japanese Yen (JPY).
1.Initial Recognition of Foreign Manufacturers
For applications reviewed via document review: the official fee is 62,600 JPY.
For applications subject to on-site inspection: the official fee is 143,900 JPY, plus applicable overseas travel expenses.
2.Modification of Foreign Manufacturer Recognition
For applications reviewed via document review: the official fee is 42,900 JPY.
For applications subject to on-site inspection: the official fee is 69,700 JPY, plus applicable overseas travel expenses.
3.Category Modification or Addition for Foreign Manufacturer Recognition
For applications reviewed via document review: the official fee is 42,900 JPY.
For applications subject to on-site inspection: the official fee is 69,700 JPY, plus applicable overseas travel expenses.
4.Registration of General Cosmetics Applications are processed via document review, with an official fee of 37,300 JPY.
5.Registration of Quasi-drugs Applications are processed via document review, with an official fee of 37,300 JPY.
6.Registration of Special Cosmetics Applications are processed via document review, with an official fee of 337,300 JPY.
7.Product Name Change (in lieu of a new registration application) Applications are processed via document review, with an official fee of 37,300 JPY.