On April 19, 2024, the China National Center for ADR Monitoring released the Cosmetics Adverse Reactions Collection and Reporting Guidelines for Registrants and Filers (Trial)(hereinafter referred to as Guidelines), to further improve China’s monitoring and evaluation system for adverse cosmetic reactions.
As of today, regulations related to adverse cosmetic reactions include, but are not limited to:
- 2021-01-01 effective, “Regulations on the Supervision and Administration of Cosmetics” (State Council [2020] Order No. 727);
- 2022-01-01, “supervision and management of cosmetic production and operation measures” (Market Supervision Administration [2021] Order No. 46);
- 2022-10-01 shall come into force, “Measures for the Administration of Adverse Reaction Monitoring of Cosmetics” (State Drug Administration [2022] No. 16);
- 2022-10-01 on-line operation, the new version of the national cosmetic adverse reaction monitoring system (State Drug Administration [2022] Notice No. 44);
- 2024-04-19 released,Cosmetics Adverse Reactions Collection and Reporting Guidelines for Registrants and Filers (Trial) (National Center for Adverse Drug Reaction Monitoring).
China’s new cosmetic regulations, taking into account the characteristics of cosmetic e-commerce sales channels, focus on enhancing the safety supervision of products purchased online. The Administrative Measures for Monitoring Adverse Reactions of Cosmetics, in addition to stipulating the obligations of registrants and filers of responsible cosmetic entities to report adverse reactions, Article 21 also stipulates the manner and timeframe in which cosmetic e-commerce platform operators are required to report to pharmacological supervision departments. Recently released guidelines (for trial implementation), detailed requirements for cosmetic registrants and filers to collect and report adverse reactions to cosmetics in terms of channels, analysis and evaluation, and submission.
HongMaoKang has compiled the main contents of the guidelines (for trial implementation). When submitting through the National Adverse Reaction Monitoring System for Cosmetics, it is necessary to pay attention to the four elements of effective reporting and the submission of cosmetic adverse reaction reports and other key parts. For more detailed information, you can leave a message on the website, or contact us by email.
If there is anything else you would like to know about cosmetic compliance, please feel free to contact us. If you have any questions about the declaration of cosmetics, toothpaste or raw materials, product labeling (including packaging), efficacy claims, advertising and publicity review, drug regulatory department review comments, product or raw material inspection reports, safety assessment reports, efficacy program design and carry out the process, welcome to contact us to consult the relevant technical services.
