Monitoring guidelines for adverse reactions to cosmetics issued in China

On 19 April 2024, China’s Centre for Drug Re-evaluation (NMPA) and the National Centre for Adverse Drug Reaction Monitoring issued final guidelines on the collection and reporting of adverse reactions to cosmetics for registrants and filers.  

The guidelines provide guidance on how to go through each step of the procedure, which includes the following:

• Collection of adverse reactions to cosmetics.

• Recording and communication of adverse reactions to cosmetics.

• Confirmation of cosmetic adverse reaction reports.

• Analysis and evaluation of adverse reactions of cosmetics.

• Submission of Cosmetic Adverse Reaction Reports.

• Quality control of Cosmetic Adverse Reaction Reports

• Cosmetic adverse reaction record management.

Categorization and Reporting Procedures

Reactions are categorized into 3 groups according to how severe they are as follows:

• General cosmetic adverse reactions

• Serious cosmetic adverse reactions

• Cosmetic adverse reactions that may cause greater social impact.

Registrants and recorders must report cosmetic adverse reactions within a specified time frame, starting from the first discovery of the reaction, which is recorded as Day 0. General adverse reactions should be reported within 30 days, serious reactions within 15 days, and reactions with social impact within 3 days.

Record-Keeping and Administration

Monitoring records should as a minimum include reporter information, information about adverse reactions, symptoms or signs, the severity of the adverse reaction, date of occurrence of adverse reactions, date of discovery or knowledge of the adverse reaction, date of reporting of the adverse reaction, name of the cosmetics used, etc.

Records, whether paper or electronic, should be kept properly to prevent loss or damage, be clear, legible, and easy to understand and have  a retention period of at least three years.