On Sep 17 NMPA released the Catalogue of Existing Certifications in Drug Regulatory System. The Catalogue is now open to public consultation until Sep 26th.
All the certifications in the Catalogue will continue to be necessary for related administrative licensing. However, the Catalogue is not fixed but will be adjusted dynamically by NMPA. Provincial and municipal MPAs are encouraged to try cancellation of partial certifications first if conditions and actual situations permit.
The cosmetic-related certifications listed in the catalog are as follows:
No. | Certifications | Purpose | Organization of Issuance | Authority of Acceptance |
1 | Overseas laboratory qualification certificates or certificates of compliance with relevant regulations | Registration of domestic special use cosmetics | Organizations accredited by overseas laboratories, supervision authorities or industry associations of the place where the overseas laboratories are located | NMPA |
Registration of imported special use cosmetics | ||||
Registration of new cosmetic ingredients | ||||
2 | Ingredient origin, quality specification and certificates of permission to use the ingredient in the manufacturing country (for those containing animal organ tissue and blood product extracts) | Registration of domestic special use cosmetics | Supervision authorities or industry associations of the manufacturing country (region) or country (region) of origin | NMPA |
Registration of imported special use cosmetics | ||||
3 | Ingredient quality specification certificate | Registration of domestic special use cosmetics | Cosmetic ingredient manufacturers | NMPA |
Registration of imported special use cosmetics | ||||
4 | Supporting document of the types and contents of all fragrances contained (for those wanting to label all fragrances) | Registration of domestic special use cosmetics | Fragrances manufacturers | NMPA |
Registration of imported special use cosmetics | ||||
5 | Cosmetic production license | Registration of domestic special use cosmetics | Provincial MPA | NMPA |
6 | Overseas Investment Enterprises Approval Certificate or Taiwan, Hong Kong and Macao Investment Enterprises Approval Certificate | Registration of domestic special use cosmetics | Commerce departments | NMPA |
7 | Certificates of quality control, GMP or manufacture qualification of manufacturers or entrusted manufacturers | Registration of imported special use cosmetics | Supervision authorities or industry associations of the country (region) of origin | NMPA |
8 | Certificate of Free Sale of imported cosmetics in the manufacturing country (region) or country (region) of origin | Registration of imported special use cosmetics | Supervision authorities or industry associations of the manufacturing country (region) or country (region) of origin | NPMA |
9 | Approval documents of new cosmetic ingredients from other countries and related dossiers (for those applying for exemption from toxicological testing) | Registration of new cosmetic ingredients | Local supervision authorities | NMPA |
10 | Housing-ownership certificate | Cosmetic production licenses | Housing administrative departments | NMPA, provincial and municipal MPAs |
11 | Practice License of Medical Institution | Registration of new cosmetic ingredients | Health administrative department | NMPA and provincial MPAs |
12 | Testing reports | Registration of domestic special use cosmetics | Testing institutions | NMPA and provincial MPAs |
Registration of imported special use cosmetics |