Overview:
On January 12,2021 China’s Health Authority, the NMPA released The Regulation “Measures of Cosmetics Registration and Filing Management” and will come into effect May 1, 2021. This blog will cover the Cosmetic Registration and Filing Management of Cosmetic Materials per Chapter III of the regulation.
The registrant:
The registrant is expected to be a legally established enterprise with the ability to monitor adverse reactions, additionally, they are expected to have a good quality management system.
Proper cosmetic research and development, safety assessments and the inspection of records, as well as proper selection of raw materials, filing are all part of the registrant’s responsibility.
Imported Cosmetics
Imported cosmetics have to be filed prior to the importation.
Changes after marketing
Cosmetics product names cannot be changed after the cosmetic has been filed, nor is the product formula allowed to be filed.
Notes on Filing:
- In case of supplementary materials, they have to be provided within 90 days, otherwise the Technical Review Agency will not approve it.
- Once the State Drug Administration is aware of the Technical Review report, it will provide a notice of either approval or not within 20 working days.
- After that, the accepting agency will issue a certificate/decision letter within 10 working days.
Validity of the Certificate
The registration certificate is valid for 5 years.
Special Cosmetics:
- For special cosmetics that have changes which do not affect the safety/efficacy, the registrant can file with the State Drug Administration.
- Those that do involve safety-related matters, substantial changes in production and efficacy claims have to apply with application for product registration changes to the State Drug Administration.
- If the product name or formula have changed, it is then a new product, and the registrant will have to reapply for registration. If the product is no longer produced, the registrant has to cancel the registration.
Renewal of Registration Certificate:
- Registrant shall apply for renewal of registration within 90 to 30 working days before expiration, and to comply with mandatory standards/technical specifications.
- Review of application material will begin within 5 days after receipt of application and registration will be issued within 10 working days for accepting, and the validity period of registration certificate will be recalculated from expiration date of the original certificate.
COSMETIC REGISTRATION AND FILING MANAGEMENT OF NEW COSMETIC MATERIALS IN CHINA PART I
The Cosmetic Registration and Filing Management of Raw Cosmetic Materials was covered in Part I of the blog.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices , pharmaceutical, cosmetic and food supplement companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
China's NMPA
China's NMPA regulates the registration of drugs, medical devices and cosmetics; as well as conduct strict review and approval for marketing of these products.