
Interpretation of the Regulations on the Management of Cosmetics Registration and Filing Materials
Release time:2021-05-28
I. Background
In June 2020, the "Regulations" were officially released. They established a series of new concepts, systems, mechanisms, and regulatory features for the registration and filing management of cosmetics and new cosmetic ingredients, creating a registration and filing management system where registrants and filers are primarily responsible for quality and safety. In January 2021, the State Administration for Market Regulation also issued the "Measures," clarifying the procedures, time limits, and requirements for the registration and filing of cosmetics and new cosmetic ingredients, and detailing the responsibilities and obligations of registrants, filers, and domestic responsible parties.
The current requirements for cosmetic registration and filing materials are scattered across more than 10 normative documents, including the "Regulations on the Acceptance of Applications for Cosmetic Administrative Licenses" and the "Regulations and Guidelines on Cosmetic Naming." These are no longer suitable for the requirements of the "Regulations" and "Measures." A systematic and comprehensive normative document on the management of cosmetic registration and filing materials is needed to standardize the registration and filing management of cosmetics and new cosmetic ingredients.
Since 2018, the National Medical Products Administration (NMPA) has been drafting the "Regulations," conducting numerous field surveys and holding special meetings, resulting in the draft "Regulations." The China National Institute for Food and Drug Control and the Cosmetics Supervision Department of the NMPA have twice solicited public opinions, receiving a total of 2033 pieces of feedback. The "Regulations" have been revised and improved based on this feedback and released according to relevant procedures.
II. Main Content
The main text of the "Regulations" consists of six chapters and sixty articles, including general provisions, user information requirements, registration and filing requirements, change requirements, renewal and cancellation requirements, and supplementary provisions. It mainly specifies the format and normative requirements for materials, user registration materials, cosmetic registration and filing materials, and change and renewal materials.
The appendix of the "Regulations" contains 24 attachments. First, it clarifies the formats of application forms, information forms, and overview forms required during the registration and filing process. Second, it provides examples of domestic responsible party authorization letters, product execution standards, and registration renewal self-inspection reports. Third, it provides detailed technical specifications for product execution standards, the reporting of relevant raw material safety information, etc.
III. Main Features
The "Regulations" provide detailed provisions on cosmetic registration and filing materials, focusing on implementing the requirements of the "Regulations," ensuring fairness and consistency, reducing the burden on enterprises, and promoting "Internet + Government Services."
(1) Implementing the Requirements of the Regulations: Article 19 of the "Regulations" stipulates the materials required for cosmetic registration and filing. First, the registration and filing materials required by the "Regulations" are all stipulated in the "Regulations," without adding any extra burden on administrative counterparts. Second, the "Regulations" detail the materials stipulated in the "Regulations" and propose technical requirements for each material based on safety.
(2) Maintaining Fairness and Consistency: The management methods for special-use cosmetics and ordinary cosmetics are different, with registration management and filing management respectively. However, the requirements for product quality and safety are the same. Therefore, the requirements for materials in the "Regulations" are consistent for both. Following the principle of fair treatment of imported and domestically produced cosmetics, the requirements for imported and domestically produced cosmetics in terms of registration and filing materials are basically consistent in the "Regulations," with separate provisions for differences between imported and domestically produced cosmetics.
(3) Reducing the Burden on Enterprises: First, it fully absorbs mature practices and experiences from existing regulations, and does not make major adjustments to the formats and content of some materials, minimizing the burden on enterprises caused by changes in material formats and content. Second, for the convenience of enterprises, templates for some materials are provided in the "Regulations" to facilitate the preparation of registration and filing materials. Third, some materials have been simplified, such as the materials for the renewal of special-use cosmetic registration, which have been further streamlined based on the "Announcement on the Implementation of the Approval of the Commitment System for the Renewal of Administrative Licenses for Special-Use Cosmetics."
(4) Promoting "Internet + Government Services": A national unified cosmetic registration and filing information service platform is being built to promote the use of e-government in registration and filing work. The main responsibilities stipulated in the "Regulations" are implemented, strengthening the user management of registrants, filers, domestic responsible parties, and manufacturers. Promoting "streamlining administration and delegating power," reducing the submission of unnecessary paper materials, and allowing enterprises to "run less errands."
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