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China Speeds Up the Approval of Cosmetics Production License

  •   3 Dec 2019
  •    Hedy He
  •  164
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    • Submission of a business license is no longer required during application for a cosmetics production license.
    • The approval period of cosmetics production license application is shortened from 60 working days to 40 working days. Administrative procedures, including alteration of the registration items in the license, reissuance of license, and cancellation of license, should be dealt with by authorities immediately.

    On Nov. 29, 2019, National Medical Products Administration (NMPA) issued the Pilot Implementation Plan for the Reform of "Separation of Business license and Certificates" (hereinafter the Implementation Plan) in 18 Pilot Free Trade Zones (PFTZs) [1]. The 18 PFTZs include Shanghai, Guangdong, Tianjin, Fujian, Liaoning, Zhejiang, Henan, Hubei, Chongqing, Sichuan, Shanxi, Hainan, Shandong, Jiangsu, Guangxi, Hebei, Yunnan, and Heilongjiang.

    The Implementation Plan pointed out that from Dec. 1, 2019, 28 business licensing items in the field of drug supervision in 18 PFTZs will be reformed in two main ways: 1) implementation of informed commitment; 2) optimization of market access services.

    Among the 28 reformed enterprise-related business licensing items, the approval of cosmetics production licenses will be streamlined by simplifying the documents required, optimizing the procedures, and reducing the time required. The details are shown in the following table.

    Item nameCompetent authorityExamination and approval departmentReform methodReform initiativesStrengthen post-market surveillance
    Cosmetic Production LicenseNMPAProvincial MPAsOptimization of market access services1. Promote the use of electronic certificates and carry out the full-process online business processing system;

    2. Documents such as business licenses are no longer required to submit. Provincial MPAs may obtain this information through inter-departmental information sharing;

    3. Reduce the approval period for production licenses from the original 60 working days to 40 working days. Local MPAs are encouraged to approve the alteration of the registration items in the license, reissuance, and cancellation of license on the spot.

    1. Strengthen the supervision and random inspection of cosmetics. Punish and announce the unqualified products according to law;

    2. Strengthen unannounced inspection of cosmetic manufacturing enterprises. Punish and announce the illegal activities according to law;

    3. Strengthen the monitoring of adverse reactions to cosmetics. Investigate products that have caused serious adverse reactions and their manufacturers. Punish the illegal activities according to law.

    Industry' s Comments
    On Nov. 20, 2018, NMPA issued the Notice of Implementing the Requirements of the State Council for the Reform of "Separation of Business license and Certificates" (hereinafter the Notice) [2], which briefly mentioned optimizing the approval process for cosmetics production licenses, including reducing the approval period to two-thirds of the original, etc. According to Pinguan [3], after the notice was issued, Jiangsu, Guangdong, has reduced the approval period from 60 working days to 40 working days or even 36 working days since Jan. 1, 2019.

    This Implementation Plan is released based on the last year' s Notice to make the measures more specific. Requirements such as "no longer required to provide a business license" and "finish business on the spot" will further speed up the approval and modification of production licenses.

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    ChemLinked Editor

    Tracking regulatory change news in Asia Pacific area and focusing on cosmetic ingredient requirements, registration/filing/notification procedures of China and South Korea.

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