To regulate and guide cosmetic registrants and filers in collecting and reporting adverse reactions related to cosmetics, in accordance with the "Regulations on the Supervision and Administration of Cosmetics," "Measures for the Supervision and Administration of Cosmetic Production and Operation," "Measures for the Administration of Adverse Reaction Monitoring of Cosmetics," and other relevant provisions, and following the requirements of the National Medical Products Administration, the National Center for Adverse Drug Reaction Monitoring has organized the formulation of the "Guidelines for Cosmetic Registrants and Filers on Collecting and Reporting Adverse Reactions to Cosmetics (Trial)," which is hereby released.
To facilitate reading, the main content is summarized as follows:
The document you provided is the "Guidelines for Cosmetic Registrants and Fliers to Collect and Report Adverse Reactions to Cosmetics (Trial)", and the following is a summary of the core content of this document:
Purpose and Scope
- Standardize and guide cosmetic registrants and record-filers (hereinafter referred to as registrants and record-filers) in carrying out the collection and reporting of adverse cosmetic reactions within China.
- In accordance with the "Regulations on the Supervision and Administration of Cosmetics," the "Measures for the Supervision and Administration of Cosmetics Production and Operation," and the "Measures for the Monitoring and Management of Adverse Reactions to Cosmetics," among other regulations.
Adverse Reaction Monitoring and Evaluation System
- The registrant or filing party shall establish an adverse reaction monitoring and evaluation system, and allocate corresponding institutions and personnel.
- The quality safety responsible person shall assist the legal representative in undertaking monitoring and management responsibilities.
- Keep confidential consumer personal privacy and other information.
- Overseas registrants and filers shall establish a coordination mechanism with domestic responsible parties.
Collection of Adverse Reactions
- Establish effective information collection channels to proactively collect adverse reactions of cosmetics on the market.
- Publish contact information through product labels, official websites, etc.
- Do not interfere with the reporter's spontaneous reporting behavior.
Recording and Reporting of Adverse Reactions
- Form original records and establish adverse reaction monitoring records.
- Ensure the authenticity, completeness, and accuracy of information transmission.
Confirmation of Adverse Reaction Reports
- Confirm the collected adverse reactions, including whether they comply with reporting principles and whether they are valid reports.
Analysis and evaluation of adverse reactions
- Analyze and evaluate adverse reactions, determine severity, and conduct causality assessment.
- Serious adverse reactions must be reported to relevant departments within the specified time frame.
Submission of Adverse Reaction Reports
- Submit reports through the national cosmetic adverse reaction monitoring system.
- Report adverse reactions within the required timeframe, and record the date when the adverse reaction was discovered or learned about.
Quality Control of Adverse Reaction Reports
- Ensure that the report content is truthful, complete, and accurate, without concealment or omission.
Adverse Reaction Record Management
- Monitoring records should include detailed information, and the numbering should be unique, continuous, and traceable.
- The record retention period shall not be less than 3 years.
Judgment of Serious Adverse Reactions
- Listed four scenarios of serious adverse cosmetic reactions.
Judgment of adverse reactions that may cause significant social impact
- Describes adverse reactions that may cause significant social impact.
Relevance Evaluation
- Evaluate the correlation between cosmetics and adverse reactions, which is assessed from five aspects.
This document provides a comprehensive set of guidelines for cosmetic registrants and filers to ensure effective monitoring, recording, analysis, reporting, and handling of adverse cosmetic reactions.
Original title: Notice on Issuing the Guidelines for Cosmetics Registrants and Fliers to Collect and Report Adverse Reactions to Cosmetics (Trial)
