China cosmetics adverse reactions self-investigation report writing guidelines for cosmetic registrants and record holders have been drafted and announced by the National Center for ADR Monitoring under the Center for Drug Reevaluation on November 8, 2024.
These guidelines aim to ensure compliance with the Regulations on the Supervision and Administration of Cosmetics and related regulations, providing clear instructions for documenting and addressing adverse reactions.
Purpose and Scope
The guidelines are designed to help cosmetic registrants and filers systematically document and analyze adverse reactions, ensuring thorough investigations into potential safety risks. Applicable to entities operating within the People’s Republic of China, the document outlines the basic structure and essential content required in self-investigation reports.
Reporting Requirements
Cosmetic registrants or filers must conduct analyses and evaluations whenever adverse reactions occur or are reported. Serious adverse reactions, or those with potential for significant public impact, require prompt action:
- Serious Adverse Reactions: Submit a self-investigation report within 20 days of notification.
- Socially Significant Reactions: Submit the report within 10 days.
Reports must be sent to provincial monitoring bodies and local drug supervision departments. Foreign registrants should work with their domestic representatives to fulfill these obligations.
Key Components of the Report
1. Basic Information:
- Case details: severity, dates, and channels of notification.
- Conclusions from initial analyses.
2. Product Details:
- Cosmetic name, registration/filing number, production batch, efficacy claims, and labeling information.
- Use details: origin, storage, shelf life, and method of application.
3. Adverse Reaction Overview:
- Affected individual’s demographics, health history, and allergy information.
- Detailed timeline of product use and reaction onset, symptoms, and medical treatments.
4. Analysis and Evaluation:
- Production and Sales: Assess risks in raw materials, formulation, quality control, packaging, transportation, and sales channels.
- Testing: Provide lab results for implicated batches and adjacent production batches.
- Correlation Analysis: Evaluate the relationship between product use and reported reactions, including diagnostic tests like patch tests.
- Monitoring Data: Analyze adverse reaction rates over three years, comparing domestic and international data.
- Expert Consultation: Summarize expert opinions on reaction severity, causality, and risk mitigation.
- Literature Review: Highlight findings from scientific literature regarding product safety risks.
- Comprehensive Evaluation: Synthesize findings to determine the product’s role in the reported reactions.
5. Conclusion: Summarize the investigation’s findings and identify potential safety risks.
6. Actions Taken: Detail risk control measures, including product recalls, reformulations, or quality system improvements.
7. Annexes: Attach relevant documentation, including registration certificates, product labels, medical diagnoses, and test reports.
Impact for Cosmetic Registrants and Filers
These guidelines reinforce the importance of robust safety monitoring and prompt response mechanisms. Registrants and record holders should establish clear processes for gathering and analyzing adverse reaction data, ensuring compliance with the NMPA’s stringent requirements.
By adhering to these standards, businesses can enhance consumer trust and minimize regulatory risks in the competitive Chinese cosmetics market.
How to Submit Comments
If you have any feedback, comments or suggestions, you can submit to wujianmin@cdr-adr.org.cn with the email subject “cosmetic adverse reaction self-investigation report writing guidelines” before December 6, 2024.
Further Information
Read the original announcement on China Cosmetics Adverse Reactions Self-Investigation Report Writing Guidelines – draft for comments.
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