On August 27, 2026, China’s National Center for Adverse Drug Reaction (ADR) Monitoring issued the Guidelines for the Preparation of Self-Inspection Reports on Adverse Reactions to Cosmetics by Cosmetic Registrants and Notifiers, which consists of five sections: Purpose, Scope of Application, General Requirements, Contents of the Self-Inspection Report, and Other Requirements. The Guideline provide clear guidance for cosmetic registrants and notifiers to standardize the preparation of adverse reaction self-inspection reports. CIRS Group has compiled and summarized the main contents of the Guidelines for your reference.
Purpose
This Guideline is formulated to regulate and guide cosmetic registrants and notifiers in preparing self-inspection reports on adverse reactions to cosmetics.
Scope of Application
This Guideline applies to guiding cosmetic registrants and notifiers in preparing self-inspection reports on adverse reactions to cosmetics within the territory of the People's Republic of China, and to helping them understand and grasp the basic requirements and contents of such reports.
General Requirements
Cosmetic registrants and notifiers shall analyze and evaluate any adverse reactions to cosmetics that they discover or become aware of, and shall, where necessary, self-inspect possible causes of adverse reactions in terms of product raw materials, formulas, production processes, production quality management, storage and transportation, and other aspects. The domestic agent shall actively assist overseas cosmetic registrants and notifiers in analyzing and evaluating adverse reactions to cosmetics that they discover or become aware of.
Where an adverse reaction is a serious one, the cosmetic registrant or record-filing entity shall, within 20 days from the date of discovering or becoming aware of the adverse reaction — or within 10 days where the adverse reaction is likely to trigger significant social impact — conduct analysis and evaluation, formulate a self-inspection report, and submit it to the provincial-level monitoring agency in the locality of the registrant, record-filing entity or domestic agent, with a copy to the local provincial-level drug regulatory authority.
CIRS Reminder
As the adverse reaction monitoring system for cosmetics continues to improve, cosmetic registrants and notifiers are facing more standardized and stringent adverse reaction reporting obligations. The Guidelines impose systematic requirements on the preparation of self-inspection reports by enterprises. The following points deserve the attention of relevant enterprises:
- Be mindful of reporting deadlines: For serious adverse reactions, analysis and evaluation must be completed and the report submitted within 20 days from the date of discovery or knowledge of the adverse reaction; for those that may trigger significant social impact, the deadline is further shortened to 10 days. Enterprises should establish an internal rapid-response mechanism to ensure completion within the statutory time limits.
- Build data archives in advance: The report requires the provision of the product sales volume, sales channels, sales regions, and adverse reaction information over the past three years, as well as the calculation of the adverse reaction reporting rate. Enterprises are advised to systematically maintain records from the time of product launch, so as to avoid data gaps when collecting information at short notice.
- Strengthen whole-chain risk screening: The cause analysis requires screening from multiple dimensions, including production, operation, and consumer use. Enterprises are advised to organize key documents such as safety assessment reports, production process control records, and quality control files in advance, for quick retrieval when needed.
- Pay attention to overseas monitoring data: For products marketed overseas, a retrospective analysis of overseas adverse reactions is also required.
- Make good use of appendices and templates: The Guidelines provide a reference format for self-inspection reports and a template for the list of individual adverse reaction reports, on the basis of which enterprises can establish internal standard operating procedures to improve the efficiency and standardization of reporting.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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Further Information:
China’s National Center for Adverse Drug Reaction (ADR) Monitoring
