Cosmetic Adverse Event Reporting Guidelines for the collection and reporting of adverse events concerning cosmetics in China have been released as a trial version by the National Medical Products Administration. These guidelines ensure that cosmetic adverse events are systematically collected, recorded, analyzed, and reported. Below is a summary of the main points:
1. Establishment of Monitoring Systems
Registrants and notifying/filing persons must establish a monitoring and evaluation system for adverse reactions, with allocated departments and personnel to manage this system. The responsible person for quality and safety must assist in overseeing the monitoring and management of adverse reactions, ensuring the confidentiality of consumer information.
2. Collection of Cosmetic Adverse Events
Registrants and filing persons must create effective channels to collect adverse reaction information from consumers, production enterprises, cosmetics operators, and medical institutions. Channels should be publicized via product labels, official websites, and other methods, ensuring accessibility and efficiency. Any changes in these channels must be updated promptly. Specific collection channels include:
- Consumer Channels:
- Publish contact information, such as telephone numbers and emails, on product labels, official websites, and other accessible methods.
- Inform consumers about how to report adverse reactions.
- Ensure that contact information is effective and updated promptly.
- Production Enterprise Channels:
- Actively collect information from entrusted manufacturers.
- Encourage written agreements requiring manufacturers to report adverse reactions.
- Cosmetics Operators Channels:
- Collect information from business operators.
- Other Channels:
- Use official websites, social media, and e-commerce platforms.
- Establish special channels on websites for collecting adverse reactions.
- Conduct literature retrievals to gather information.
3. Recording and Reporting of Adverse Events
Original records of cosmetic adverse events must be maintained, including phone calls, emails, or screenshots. Information must be transmitted accurately, without deletion or omission, and reports should meet time limit requirements. Training should be provided to personnel to ensure proper information transmission.
Required Information:
- Original Records: Phone calls, emails, or screenshots.
- Transmission Accuracy: Ensure information is authentic, complete, and accurate.
- Time Limits: Clarify the time limit for information transmission.
4. Confirmation and Analysis of Adverse Reaction Reports
Adverse reactions must be confirmed, ensuring they adhere to reporting principles. Effective reports must include:
- an identifiable reporter
- adverse reaction,
- other relevant information,
- and cosmetics used
- analysis should determine the severity and relevance of adverse reactions, considering factors such as the relationship between the cosmetic use and the adverse reaction, recurrence of reactions, and exclusion of other causes.
The severity of the adverse event should be classified accordingly:
- General Adverse Reactions
- Serious Adverse Reactions: include significant harm, systemic damage, hospitalization, or life-threatening effects.
- Social Impact Reactions: affect multiple individuals or cause widespread concern.
The relevance should be determined with the following information:
- Time Relationship: Between cosmetic use and adverse reaction.
- Discontinuation Effect: Consistency of adverse reactions with stopping use.
- Recurrence: Whether the same reaction occurs again with re-use.
- Other Factors: Exclusion of other diseases and exposures.
- Laboratory Results: Correlation between adverse reactions and cosmetic use.
5. Submission of Reports
Reports should be submitted through China’s National Cosmetics Adverse Reaction Monitoring System, with the start date of reporting recorded as day 0. The time limits for reporting are:
- General Reactions: Within 30 days.
- Serious Reactions: Within 15 days.
- Social Impact Reactions: Within 3 days.
6. Quality Control of Reports
Registrants and filers must ensure the truthfulness, completeness, and accuracy of reports. They must obtain detailed adverse reaction information and complete the report forms comprehensively.
7. Record Management
Records, including monitoring and original records, must be truthful, complete, accurate, and traceable. Records should be categorized, catalogued, and retained for at least three (3) years from the reporting date. Key Record Details should include:
- Reporter Information: Name or surname, gender, age, contact information.
- Adverse Reaction Information: Date of occurrence, symptoms or signs.
- Cosmetics Information: Product name, registration certificate number or filing number, production batch number, start and stop dates of use.
- Diagnosis and Treatment: Information from medical institutions.
- Serious Reactions: Reasons for adverse reactions, analysis and evaluation, follow-up risk control measures.
- Unique Numbering: Assign unique, continuous, and traceable numbers to all adverse reactions.
- Retention Period: Keep records for at least 3 years from the reporting date.
In summary, registrants and filers must ensure comprehensive systems for monitoring, collecting, recording, analyzing, and reporting adverse reactions to cosmetics, complying with Chinese regulations to maintain product safety and consumer protection. This involves establishing effective communication channels, ensuring accurate record-keeping, timely report submissions, and thorough analysis and evaluation of adverse reactions.
Further information
Read the original announcement on China Cosmetic Adverse Reaction Collection and Reporting guidelines for cosmetic registrants and filters – trial.
Read our previous article on Cosmetics adverse reactions collection and reporting guidelines for registrants and filers (Trial) – Draft issued.
To know more about the Measures for Cosmetics Adverse Reaction Monitoring, click here.
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