China NMPA Clarifies Requirements for Completing Cosmetic Adverse Reaction Report

On 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 (hereinafter referred to as “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.

Regarding the filling-in requirements for the adverse reaction report form, the Center for Drug Reevaluation, NMPA and National Center for Adverse Drug Reaction (ADR) Monitoring sent a Guide Manual for Filling in the Cosmetic Adverse Reaction Report Form (hereinafter referred to as “Guide Manual”) to provincial centers for adverse reaction monitoring on September 23, 2022, and published it on the system’s homepage.

The Guide Manual clarifies the filling-in requirements for two types of adverse reaction reports, namely, individual cases of adverse reactions, and adverse reactions that may cause greater social impact. The content of the Guide Manual includes the items required to be filled in the report, filling-in instructions, and noteworthy points. Specifically, the items to be filled in the two types of reports are as follows.