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NMPA to Retain 12 Administrative Certifications Related to Cosmetics

  •   20 Sep 2019
  •    Angelita Hu
  •  501
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    Takehome:

    • NMPA recently reformed the administrative certification framework for several sectors. After this reform 12 certifications with relevance to administration of special use cosmetics, new cosmetic ingredients and production licensing etc. have been retained which will continue to be necessary for related administrative licensing.

    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.CertificationsPurposeOrganization of IssuanceAuthority of Acceptance
    1Overseas laboratory qualification certificates or certificates of compliance with relevant regulationsRegistration of domestic special use cosmeticsOrganizations accredited by overseas laboratories,  supervision authorities or industry associations of the place where the overseas laboratories are locatedNMPA
    Registration of imported special use cosmetics
    Registration of new  cosmetic ingredients
    2Ingredient 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 cosmeticsSupervision authorities or industry associations of the manufacturing country (region) or country (region) of originNMPA
    Registration of imported special use cosmetics
    3Ingredient quality specification certificateRegistration of domestic special use cosmeticsCosmetic ingredient manufacturersNMPA
    Registration of imported special use cosmetics
    4Supporting document of the types and contents of all fragrances contained (for those  wanting to label all fragrances)Registration of domestic special use cosmeticsFragrances manufacturersNMPA
    Registration of imported special use cosmetics
    5Cosmetic production licenseRegistration of domestic special use cosmeticsProvincial MPANMPA
    6Overseas Investment Enterprises Approval Certificate or Taiwan, Hong Kong and Macao Investment Enterprises Approval CertificateRegistration of domestic special use cosmeticsCommerce departmentsNMPA
    7Certificates of quality control, GMP or manufacture qualification of manufacturers or entrusted manufacturersRegistration of imported special use cosmeticsSupervision authorities or industry associations of the country (region) of originNMPA
    8Certificate of Free Sale of imported cosmetics in the manufacturing country (region) or country (region) of originRegistration of imported special use cosmeticsSupervision authorities or industry associations of the manufacturing country (region) or country (region) of originNPMA
    9Approval documents of new cosmetic ingredients from other countries and related dossiers (for those applying for exemption from toxicological testing)Registration of new  cosmetic ingredientsLocal supervision authoritiesNMPA
    10Housing-ownership certificateCosmetic production licensesHousing administrative departmentsNMPA, provincial and municipal MPAs
    11Practice License of Medical InstitutionRegistration of new cosmetic ingredientsHealth administrative departmentNMPA and provincial MPAs
    12Testing reportsRegistration of domestic special use cosmeticsTesting institutionsNMPA and provincial MPAs
    Registration of imported special use cosmetics

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