BackgroundOn October 1, 2022, with the implementation of Measures for the Management of Cosmetic Adverse Reaction Monitoring, China NMPA launched the upgraded new version of the National Cosmetic Adverse Reaction Monitoring System to facilitate stakeholders to submit reports. Where cosmetic registrants, notifiers, entrusted production enterprises, operators, and/or medical institutions discover or become aware of any cosmetic adverse reaction, they shall submit a report through the adverse reaction monitoring system. |
On November 25, 2022, the Center for Drug Reevaluation and the National Center for Adverse Drug Reaction (ADR) Monitoring of China published the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public feedback. 1 On April 19, 2024, the finalized version of the Guidelines was released. 2
The Guidelines provides instructions for registrants and notifiers on the collection and reporting of cosmetic adverse reactions, including stages from collection, recording, transmission, to report confirmation, analysis and evaluation, submission, quality control, and record management. The key contents of the Guidelines are as follows:
1. Adverse reaction collection
Regarding adverse reaction collection, the Guidelines clarifies that registrants and notifiers shall establish effective information collection channels with consumers, entrusted production enterprises, cosmetic operators, and medical institutions, and actively collect adverse reactions of their cosmetics sold on the market.
For instance:
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