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New Functions of Filling in the Efficacy Claims and Annual Report of Ordinary Cosmetics Officially Launched

from CIRS by

On December 31, 2021, a notice was issued on the cosmetics registration and filing information service platform regarding the upgrading of ordinary cosmetics filing management system. The system was scheduled to be upgraded from 19:00 to 24:00 on December 31, 2021 to add the function of filling in efficacy claims and product annual report.

Efficacy Claims

Regulatory requirements

The article 22 of "the Cosmetics Supervision and Administration Regulations" shows that the cosmetics efficacy claims shall have sufficient scientific basis. Cosmetic registrants and filers should publish the summary of efficacy claims based on the literature, research data or product efficacy evaluation data on the special site of NMPA for social supervision.

The Article 4 of "Standards for the Evaluation of Cosmetics Efficacy Claims" indicates that when cosmetics registrants or filers apply for the registration or filing of cosmetics, the abstract of efficacy claims of products should be upload to the special website designated by the National Medical Products Administration according to the regulatory requirements.

NMPA Notice regarding the Issue of Standards for the Evaluation of Cosmetics Efficacy Claims (Notice No. 50, 2021):

Since January 1, 2022, cosmetic registrants and filers should evaluate the efficacy claims of cosmetics according to the regulatory requirements when applying for the registration of special cosmetics or the filing of ordinary cosmetics, and the summary of the basis for product efficacy claims should be uploaded to the NMPA designated special website.

For the cosmetics that have been registered or filed before May 1, 2021, cosmetic registrants and filers should, in accordance with the requirements of the "Standards", evaluate the efficacy of cosmetic claims, and upload a summary of the basis for product efficacy claims before May 1, 2023.

For cosmetics that have been registered or filed between May 1, 2021 and December 31, 2021, the registrants and the filers should evaluate the efficacy claims of cosmetics and upload a summary of the basis of product efficacy claims in accordance with the requirements of the "Standards" before May 1, 2022.

Info filling in the system

There is a new function of filling in the efficacy claims on the ordinary cosmetics filing management system. When filling in the filing number or Chinese product name, the product info can be searched but can’t be compiled in the interface of efficacy claims.

The content of "Product Efficacy Claim" should be consistent with the relevant information of product classification and labelling content in the filing materials. For the efficacy exempted from submission of efficacy evaluation data, an option of "No" can be chose in the column of "Product Efficacy Claim", but this item cannot be deleted.

The specific contents to fill in is same as annex 4 sample abstract of the basis of cosmetics efficacy claims.

For special cosmetics, the basic product information is automatically obtained according to the registration data that has been filled in the system. In case the special cosmetics registration dossiers have been accepted but not approved, the basic information of the efficacy basis cannot be modified in the system.

The required info to fill in the info of efficacy basis of special cosmetics is almost same as ordinary cosmetics, but the interface is slightly different.

For the efficacy exempted from submission of efficacy evaluation data, it is no need for the registrant to confirm or delete it because of the automatic elimination by the system, which is different from the efficacy function settings of ordinary cosmetics.

Products Annual Report

Regulatory requirements

Article 37 of the Measures for the Administration of Cosmetic Registration and Filing: The filers of ordinary cosmetics shall report annually to the competent authority regarding the status of production and import, as well as the compliance with laws and regulations, compulsory national standards and technical specifications.

Article 53 of Provisions on the Administration of Cosmetics Registration and Filing Data shall include the following contents: (1) the general situation of production and import of products, as well as the production stoppage during the period; (2) Self-examination of products conforming to laws and regulations, mandatory national standards and technical specifications.

NMPA Announcement regarding Provisions on the Administration of Cosmetics Registration and Filing Data (No. 35, 2021): since January 1, 2022, the annual report system will be implemented uniformly for ordinary cosmetics filed on both the old and new registration and filing platform. The filer shall submit the annual report of ordinary cosmetics that have been filed for one year through the new registration and filing platform from January 1 to March 31 each year.

Info filling in the system

After logging in to the cosmetics registration and record information service platform, there is an annual report filling function in the "ordinary cosmetics filing management system". The interface lists all ordinary cosmetics that the filing time has been over one year including the cancelled products.

Filers need to identify the products whether there is an order to correct, whether there is a stopped production/suspended import, whether there is a comprehensive self-examination and the results meet the requirements, and whether there is an unqualified or recalled case for the sampling inspection. In case of suspension of production /import, or sampling inspection/recall, specific information should be submitted in the column of "Details".

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