In order to implement the “Management Measures for Adverse Reaction Monitoring of Cosmetics“, standardize the collection and reporting of adverse reactions to cosmetics, guide and help cosmetic registrants and filling person to carry out related work on the monitoring of cosmetic adverse reactions, the center of drug evaluation from NMPA researched and drafted the “Cosmetic Products Adverse Reaction Collection and Reporting Principles for Cosmetics registrants and filling person (Draft for Comment)” is now open to the public for comments.
Please send feedback to the email [email protected] before December 9, 2022, and indicate the subject of the email “Cosmetic registrants and filling person Cosmetic Adverse Reaction Collection and Reporting Guiding Principles Opinion”.
Cosmetics registrants and filling person
Cosmetic Products Adverse Reaction Collection and Reporting Principles (Trial) (draft for comments)
In order to standardize the collection and reporting of cosmetic adverse reactions, guide cosmetics registrants and filling person (hereinafter referred to as “registrants, filling person”) Carry out work related to the reporting of Cosmetic Production and Operation Supervision and Management Measurescosmetic adverse reactions and formulate this guiding principle in accordance with relevant regulations such as the
This guideline applies to the collection and reporting of cosmetic adverse reactions by registrants and filling person.
Registrants and filling person should establish a monitoring and evaluation system for active collection, reporting, analysis and evaluation of cosmetic adverse reactions, and equip institutions and personnel suitable for their products to carry out monitoring of cosmetic adverse reactions in accordance with regulations.
The person in charge of quality and safety of the registrant and recorder shall assist the legal representative and the main person in charge to undertake the monitoring and management duties of cosmetic adverse reactions.
- Collection of adverse reactions to cosmetics
Registrants and recorders should establish effective information channels for consumers (individuals), entrusted manufacturers, cosmetics operators, etc., and actively collect adverse reactions of their marketed cosmetics.
Registrants and filling person shall not interfere with the reporter’s voluntary reporting behavior for any reason or means.
1.1 Consumer (individual) channel
registrants and filling person should announce to the public their contact information such as phone numbers and e-mails through product labels and official websites and other ways that are convenient for consumers to know, inform consumers of the channels for reporting adverse reactions of cosmetics, and ensure that Effective contact information and smooth channels for information collection. If there is a change in the way to report adverse reactions to cosmetics, it should be updated in a timely manner through product labels and official websites.
1.2 The channel
registrants and filling person of entrusted production enterprises should actively collect information on adverse reactions of cosmetics from entrusted production enterprises and ensure smooth reporting channels.
The registrant and the filing party collect adverse reaction information of cosmetics through the entrusted production enterprise. The two parties should agree on the responsibilities of the entrusted production enterprise in the entrustment agreement, and clarify the requirements for information collection and transmission. Registrants and filling person should regularly assess the ability of the entrusted production company to perform information collection, and take necessary measures to ensure the quality of cosmetic adverse reaction information collection.
1.3 Cosmetics operator channel
registrants and filling person should actively collect cosmetic adverse reaction information from cosmetics operators and ensure smooth reporting channels.
1.4
Registrants and filling person can use the company’s official website, social media/platforms, etc. to collect cosmetic adverse reaction information on the Internet and related channels, such as establishing a special path for cosmetic adverse reaction reports on the official website, and providing guidance on reporting methods, report forms, and report content . Registrants and filling person can provide access to complete product labels through the company’s official website.
1.5 Academic literature
encourages registrants and filling person to actively collect cosmetic adverse reaction information found in literature searches. Registrants and filling persons can formulate literature retrieval norms or procedures, such as specifying retrieval frequency, time range, literature sources, literature types, and retrieval strategies.
2 Recording, transmission and verification
of cosmetic adverse reactions In order to ensure the traceability of cosmetic adverse reaction information collection, transmission, and reporting, registrants and filling person should form original records of information related to cosmetic adverse reactions, and on the basis of summarizing the original records On the one hand, establish cosmetic adverse reaction monitoring records (covering cosmetic adverse reaction collection, analysis and evaluation, reporting, taking risk control measures and other records related to adverse reaction monitoring).
2.1 Records
There should be original records of cosmetic adverse reaction information collected in various ways, such as telephone calls and emails. For regular collection channels such as telephone records, an original record form should be established.
2.2 Transfer
registrants and filling person can organize training and education to make all company personnel aware that the authenticity of the original records of cosmetic adverse reactions should be maintained during the process of transferring the original records of cosmetic adverse reactions from the company’s first receiver to the department in charge of cosmetic adverse reaction monitoring and completeness without deletion or omission. Registrants and filling person should specify the time limit for the transmission of cosmetic adverse reaction information to ensure that cosmetic adverse reactions meet the reporting time limit requirements. All missing information and changes to original records should be noted.
2.3 Verification
The registrant and filing party shall evaluate the authenticity, completeness and accuracy of the collected cosmetic adverse reaction information, and verify the relevant information if there is any doubt.
3 Confirmation of Cosmetic Adverse Reaction Report Cosmetic adverse reactions
collected through various channels shall be confirmed. The content that needs to be confirmed mainly includes: whether it conforms to the reporting principles, whether it is an effective report, whether it is a repeated report, etc. For cosmetic adverse reactions that are not submitted to the monitoring agency, the reason for not submitting should be recorded, and monitoring records should be kept.
3.1 Reporting principles
Cosmetic adverse reaction reports follow the principle of reporting when suspected, and any suspected human damage related to the use of cosmetics should be reported. That is, if it cannot be clearly ruled out that the damage to the human body is related to the use of cosmetics, it should be reported.
3.2 Effective report
An effective report should include the following four elements (referred to as the four elements): identifiable reporter, identifiable adverse reaction recipient, adverse reaction information, and cosmetics used information. If the four elements are incomplete, the report will be considered invalid and should be supplemented before reporting.
“Identifiable” refers to the ability to confirm the existence of adverse reactions and reporters. A reporter is identifiable when he or she has information such as name or affiliation. When at least the first two items of information such as the name or surname, gender, age, and contact information of the person who has an adverse reaction are available, it is an identifiable person who has an adverse reaction.
3.3 Repeated reports
that are consistent in the information of adverse reactions, suspected cosmetics, use of cosmetics, information on adverse reactions, time of use of cosmetics, and time of adverse reactions are repeated reports. In order to avoid duplicate reports due to different collection channels, registrants and filling person should check the received reports for duplicates, and report after eliminating duplicate reports. Repeated reports shall be archived and kept in the form of monitoring records. Reports that cannot be determined to be duplicates shall be reported in a timely manner.
4 Analysis and evaluation of cosmetic adverse reaction reports
After confirming the cosmetic adverse reactions collected through various channels, the registrant and filer shall analyze and evaluate the severity of adverse reactions and the correlation between adverse reactions and products in each report. Registrants and filling person shall analyze and evaluate serious cosmetic adverse reactions that may cause greater social impact in a timely manner in accordance with regulations, and form a self-inspection report and submit it to the local provincial monitoring agency, and at the same time submit it to the local provincial drug regulatory department.
4.1 Judgment of
serious cosmetic adverse reactions Serious cosmetic adverse reactions refer to reactions caused by normal use of cosmetics that cause one of the following damages:
(1) Cause temporary or permanent loss of function and affect normal human body and social functions, such as persistent skin lesions Non-healing, scar formation, permanent hair loss, obvious loss of appearance, etc.;
(2) Causes systemic damage to the human body, such as abnormal liver and kidney function, anaphylactic shock, etc.;
(3) Causes hospitalization or is deemed necessary by medical institutionscausing
other serious damage to the human body, threatening life or causing death.
4.2 Judgment of cosmetic adverse reactions that
may cause greater social impact Adverse cosmetic reactions that may cause greater social impact refer to cosmetic adverse reactions that cause greater social impact or cause serious damage to many people due to the normal use of the same cosmetic in a certain area reaction.
4.3 Correlation evaluation
Correlation evaluation is to evaluate the correlation between suspected cosmetics and adverse reactions. The correlation between cosmetics and adverse reactions experienced by consumers is a complex issue involving many influencing factors. Registrants and filling person should try their best to obtain consumers’ adverse reaction information, diagnosis and treatment conditions, and various inspection materials, ask consumers about their makeup history, past disease history, and allergy history, and conduct inspections based on the acquired information and relevant knowledge and experience. Comprehensive analysis. At present, the evaluation of the correlation of adverse reactions of cosmetics in China mainly follows the following five principles:
(1) Is there a reasonable time relationship between the use of cosmetics and the occurrence of adverse reactions?
(2) Is the change of adverse reaction consistent with the discontinuation of suspicious cosmetics?
(3) Does the same reaction occur again when the suspicious cosmetic is used again?
(4) Are possible factors such as other diseases and other contacts of patients/consumers excluded?
(5) Laboratory test results show that the adverse reaction is related to the use of cosmetics?
According to the above five principles, the correlation evaluation results of cosmetic adverse reactions are divided into 5 levels: positive, probable, possible, possibly irrelevant, and impossible to evaluate (the results of the correlation evaluation of the 5 levels should all be reported).
5 Submission of Cosmetic Adverse Reaction Report
5.1 Submission route
Registrant and recorder shall designate a contact person or contact department to submit the cosmetic adverse reaction report through the National Cosmetic Adverse Reaction Monitoring System, and maintain and update the system registration information in a timely manner.
5.2 Time limit for reporting
Cosmetic adverse reaction reports should be submitted according to the time limit. The start date of the reporting time limit is the date when the registrant or filer first discovers or learns about the adverse reaction of the cosmetic and meets the requirements of the effective reporting standard, which is recorded as the first day. The date of Day 1 needs to be recorded to assess whether the report was submitted in a timely manner.
If it is a general cosmetic adverse reaction, it should be reported within 30 days from the date of discovering or learning of the cosmetic adverse reaction. If it is a serious cosmetic adverse reaction, it should be reported within 15 days from the day of discovery or learning. Adverse reactions should be reported within 3 days from the date of discovery or learning.
If there are new discoveries or cognitions about adverse reactions and analysis and evaluation results, supplementary reports shall be made in a timely manner.
- Cosmetic adverse reaction report quality control
registrants and filling person should ensure that the contents of the report are true, complete and accurate. Registrants and filling person shall truthfully record the adverse reactions of cosmetics they have learned in accordance with the requirements of regulations, and shall not conceal or omission of reports. It is required to obtain detailed information on cosmetic adverse reactions as much as possible, and fill in all items in the cosmetic adverse reaction report form as completely as possible. Registrants and filling person shall be responsible for the quality of the cosmetic adverse reaction report form. For specific filling requirements, please refer to the “Guidelines for Filling in the Cosmetic Adverse Reaction Report Form”.
7 Management of Cosmetic Adverse Reaction Records
in this guideline include the monitoring records of adverse reaction reports and various original records (such as telephone records, emails or screenshots, literature search records), and the submitted “Cosmetic Adverse Reaction Case Report Form”. “Wait.
The monitoring records should at least include: reporter information, information on adverse reactions, symptoms or signs, severity of adverse reactions, date of occurrence of adverse reactions, date of discovery or learning of adverse reactions, date of adverse reactions reported, name of the cosmetic used (the name of the cosmetic should be Consistent with the name marked on the label, and cannot be abbreviated or abbreviated), etc. It should be collected and recorded as much as possible: special cosmetics registration certificate number or general cosmetics record number, production batch number, date of start of use and date of discontinuation of the cosmetic used in adverse reactions, medical institution diagnosis and treatment, etc. For cosmetic adverse reactions that are serious and may cause relatively large social impacts, the registrant and filer shall also record the possible causes of adverse reactions, analysis and evaluation, and follow-up risk control measures.
Monitoring records shall be objective, true and accurate. Registrants and filling person shall number all cosmetic adverse reaction reports collected, and the numbers shall be unique, continuous and traceable. According to the number, it can be traced back to the cosmetic adverse reaction report reported to the national cosmetic adverse reaction monitoring system.
Records can be paper records or electronic files. Electronic documents should be properly preserved and properly backed up to avoid accidental loss or damage. Paper records should be clear, readable and easy to understand, classified and cataloged, and safety control and archiving procedures established. The record retention period shall not be less than 3 years from the date of the report. Personal privacy and other information learned during the monitoring of cosmetic adverse reactions should be kept confidential.
