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China Clarifies Specific Practices of Cosmetic Adverse Reaction Monitoring and Reporting


On Oct. 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 find or learn any cosmetic adverse reaction, they shall submit a report through the adverse reaction monitoring system.

On Nov. 25, 2022, the Center for Drug Reevaluation and the National Center for ADR Monitoring of China released the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public comments. 1 Any suggestions can be mailed before Dec. 9.

The draft is to guide registrants and notifiers to carry out the collection and reporting of cosmetic adverse reactions, covering collection, recording, transmission, verification, report confirmation, analysis and evaluation, submission, quality control, and record management. The main contents are as follows.

Establishing effective information channels

Regarding the collection of adverse reactions, the draft clarifies that registrants and notifiers shall establish effective information channels for consumers (individuals), entrusted production enterprises, cosmetic operators, etc., and actively collect adverse reactions of their cosmetics sold on the market.

For example,

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