Cosmetics adverse reactions collection and reporting draft guidelines for registrants and filers (trial) are formulated according to the cosmetics supervision and administration regulations (CSAR), the measures for the supervision and administration of the production and operation of cosmetics, and the measures for the monitoring of adverse reactions of cosmetics.
Once the draft guidelines have been finalized and implemented, the registrants and filers shall establish a monitoring and evaluation system for the active collection, reporting, analysis and evaluation of adverse cosmetic reactions, allocate institutions and personnel appropriate to their products, and carry out monitoring of adverse cosmetic reactions in accordance with the requirements.
The person in charge of quality and safety shall assist the domestic responsible agent to undertake monitoring and management duties of cosmetic adverse reactions.
Collection of adverse reactions to cosmetics
Registrants and filers should establish effective information channels for consumers (individuals), entrusted manufacturers, cosmetics operators, etc., and actively collect adverse reactions of cosmetics on the market.
Registrants and filers shall not interfere with the spontaneous reporting of the reporter for any reason or means.
Recording, transmission and verification of adverse cosmetic reactions
In order to ensure the traceability of cosmetic adverse reaction information collection, transmission, and reporting, registrants and filers should form original records of information related to cosmetic adverse reactions, and on the basis of summarizing the original records, establish cosmetic adverse reaction monitoring records (covering Cosmetic adverse reaction collection, analysis and evaluation, reporting, risk control measures and other records related to adverse reaction monitoring).
- Records:
- Information on adverse reactions to cosmetics collected through various channels, such as telephone calls, emails, etc., should be recorded originally.
- Delivery:
- The registrant and filer may, through means such as organizing training and education, enable all personnel of the company to know that the original record of adverse cosmetic reactions is transmitted by the first recipient of the company to the department responsible for monitoring adverse cosmetic reactions, and shall maintain the authenticity and completeness of the records, and shall not be deleted or omitted.
- Registrants and filers should clarify the time limit for the transmission of information on adverse cosmetic reactions to ensure that adverse cosmetic reactions meet the requirements of the reporting time limit. All missing information and changes to the original record should be noted in a note.
- Verification:
- Registrants and filers shall assess the authenticity, completeness and accuracy of the collected information on adverse reactions to cosmetics, and verify the relevant information if in doubt.
Confirmation of adverse cosmetic reaction reports
Adverse cosmetic reactions collected through various channels should be confirmed.
- Reporting Principles:
- The report of adverse reactions to cosmetics follows the principle of suspicious reporting, and any suspected human damage related to the use of cosmetics should be reported.
- Effective Reporting:
- Effective reporting should include the following four elements (referred to as the four elements): identifiable reporter, identifiable adverse reaction, adverse reaction information, and information on the cosmetics used.
- Duplicate Reporting:
- Reports that are consistent with information on people who have adverse reactions, suspected cosmetics, use of cosmetics, adverse reaction information, duration of use of cosmetics, and time of occurrence of adverse reactions are repeated reports.
Analysis and evaluation of adverse cosmetic reaction reports
After confirming the adverse reactions of cosmetics collected through various channels, the registrant and recordation applicant shall analyze and evaluate the severity of adverse reactions and the correlation between adverse reactions and products of each report. Registrants and filers shall, in accordance with the requirements of laws and regulations, promptly analyze and evaluate adverse reactions to cosmetics that are serious and may cause greater social impact, and form a self-inspection report and submit it to the provincial monitoring agency where it is located, and at the same time to the local provincial drug regulatory department.
- Judgment of serious cosmetic adverse reactions:
- Serious adverse cosmetic reactions refer to reactions that cause one of the following damages caused by normal use of cosmetics:
- Causing temporary or permanent loss of function and affecting normal human and social functions, such as persistent non-union of skin lesions, scarring, permanent hair loss, obvious disfiguring changes, etc.;
- Causing systemic damage to the human body, such as abnormal liver and kidney function, anaphylactic shock, etc.;
- Causing hospitalization or hospitalization deemed necessary by the medical institution;
- Causing other serious damage to the human body, endangering life or causing death.
- Serious adverse cosmetic reactions refer to reactions that cause one of the following damages caused by normal use of cosmetics:
- Judgment of adverse reactions of cosmetics that may cause greater social impact:
- Adverse reactions of cosmetics that may cause greater social impact refer to adverse reactions of cosmetics that cause greater social impact or cause serious damage to many people due to the normal use of the same cosmetic product in a certain area.
- Relevance evaluation
- Correlation evaluation is the evaluation of suspected correlation between cosmetic products and adverse effects. At present, the correlation evaluation of adverse reactions of cosmetics in China mainly follows the following five principles:
- Is there a reasonable time relationship between the use of cosmetics and the occurrence of adverse reactions?
- Is the change in adverse reactions consistent with the discontinuation of suspected cosmetics?
- Will the same reaction occur again with the use of the suspect cosmetics?
- Are possible factors such as other diseases and other exposures of patients/consumers excluded?
- Are the results of laboratory tests related to the use of cosmetics?
- According to the above five principles, the results of the correlation evaluation of adverse cosmetic reactions are divided into 5 levels: positive, likely, probable, possibly irrelevant, and unable to evaluate (the results of the 5-level correlation evaluation should be reported).
- Correlation evaluation is the evaluation of suspected correlation between cosmetic products and adverse effects. At present, the correlation evaluation of adverse reactions of cosmetics in China mainly follows the following five principles:
Submission of adverse cosmetic reaction reports
- Commit Path
- The registrant and recordation applicant shall act as the designated contact person or contact department, submit the adverse reaction report of cosmetics through the national adverse cosmetic reaction monitoring system, and maintain and update the registration information of the system in a timely manner.
- Reporting Time Limits
- The report of adverse reactions to cosmetics should be submitted in accordance with the time limit. The start date of the reporting time limit is the date when the registrant or filer first discovers or learns of the adverse reaction of the cosmetic product and meets the requirements of the valid reporting standard, which is recorded as the first day.
- Adverse reactions of general cosmetics shall be reported within 30 days from the date of discovery or knowledge of adverse cosmetic reactions, serious adverse reactions of cosmetics shall be reported within 15 days from the date of discovery or knowledge, and adverse reactions of cosmetics that may cause greater social impact shall be reported within 3 days from the date of discovery or knowledge.
- Where there are new discoveries or cognition of adverse reactions and analysis and evaluation results, supplementary reports shall be made in a timely manner.
Quality control of cosmetic adverse reaction reports
Registrants and filers shall ensure that the content of the report is true, complete and accurate. Registrants and filers shall truthfully record the adverse reactions of cosmetics they have learned in accordance with the requirements of laws and regulations, and shall not conceal or omit reports.
Adverse cosmetic reaction record management
The records in these guidelines include monitoring records of adverse reaction reports and various original records (such as telephone records, email or screenshots, literature search records), and the “Individual Report Form of Adverse Reactions to Cosmetics” that have been submitted.
Records can be paper records or electronic documents. The record retention period shall not be less than 3 years from the date of reporting.
Further information
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