导航菜单
On August 27, 2026, China's National Center for ADR Monitoring released the Guidelines for Preparing Self-Inspection Reports on Adverse Reactions to Cosmetics by Registrants and Notifiers, providing guidance on the preparation of adverse reaction self-inspection reports by cosmetic registrants, notifiers, and domestic responsible persons in China. Key points of the Guidelines include:
The Guidelines apply to cosmetic registrants, notifiers, and domestic responsible persons in China.
Serious adverse reactions: A self-inspection report must be submitted within 20 days from the date the adverse reaction is identified/known.
Adverse reactions that may have a significant social impact: The report must be submitted within 10 days from the date they are identified/known.
The self-inspection should cover basic product and patient information, causality assessment, root-cause analysis across the entire product chain—including manufacturing, formulation, raw materials, distribution, and use—as well as sales data and adverse reaction incidence rates over the previous three years, expert consultation opinions, and third-party testing reports, where applicable.
The report should include the self-inspection conclusion and the risk control measures already taken or planned, such as product recalls and process improvements.
The Guidelines emphasize the authenticity, completeness, and traceability of adverse reaction data and supporting information.
