China Clarifies Specific Practices of Cosmetic Adverse Reaction Monitoring and Reporting

On Nov. 25, 2022, the Center for Drug Reevaluation and the National Center for ADR Monitoring of China released the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public comments. ¹ Any suggestions can be mailed [email protected] before Dec. 9.

The draft is to guide registrants and notifiers to carry out the collection and reporting of cosmetic adverse reactions, covering collection, recording, transmission, verification, report confirmation, analysis and evaluation, submission, quality control, and record management. The main contents are as follows.

Establishing effective information channels

Regarding the collection of adverse reactions, the draft clarifies that registrants and notifiers shall establish effective information channels for consumers (individuals), entrusted production enterprises, cosmetic operators, etc., and actively collect adverse reactions of their cosmetics sold on the market.

For example,

• for the consumer (individual) channel, registrants and notifiers shall publish telephone number, e-mail and other contact information to the public through product labels, official websites and other ways convenient for consumers to know, informing consumers of the ways to report cosmetic adverse reactions;

• in terms of entrusted production enterprise, registrants/notifiers and entrusted production enterprises shall agree on the responsibilities of the entrusted production enterprises in the entrustment agreement and specify the requirements for information collection and transmission.

Ensuring the traceability of adverse reaction reports

According to the draft, when collecting and reporting adverse reactions, "recording, transmission and verification" procedures are required to ensure the traceability of reports.

In addition to keeping the original records (such as phone call records and e-mails) of the adverse reaction information, registrants and notifiers shall compile the monitoring records (covering the collection of cosmetic adverse reactions, analysis and evaluation, reporting, and implementation of risk control measures).

Regarding the transmission and verification of adverse reactions, registrants and notifiers shall specify the time limit for the transmission of adverse reaction information, so as to ensure that the report of adverse reactions meets the time limit requirements. All missing information and changes to the original records shall be specified in notes. Besides, registrants and notifiers shall assess the authenticity, completeness and accuracy of the collected information.

Confirming adverse reaction report before submission

Regarding report submission, the draft emphasizes that adverse reactions collected through various channels should be confirmed in terms of the compliance to the reporting principles, and the validity of reports in avoid of repeated reports. Specifically,

• the reporting of cosmetic adverse reactions shall follow the principle of immediate reporting once suspicion occurs. That is, if the possibility of human damage related to the use of cosmetics cannot be ruled out, the situation shall be reported;

• the valid report shall include four elements: identifiable reporter, identifiable person with adverse reactions, adverse reaction information, and information of the cosmetics used;

• registrants and notifiers shall conduct repeating-check on the received reports, and submit after eliminating repeated reports.

For cosmetic adverse reactions not submitted to the monitoring institutions, the reasons for non-submission shall be recorded and the monitoring records shall be kept.

Analysis and evaluation is an important step

After confirming the adverse reactions, registrants and notifiers shall conduct analysis and evaluation on the severity of adverse reactions and the relevance between the adverse reactions and the concerned products. A self-inspection report shall be compiled and submitted to the provincial-level monitoring institution and provincial-level medical products administration department.

Regarding the judgment of severe adverse reactions, the draft gives the following four examples:

In terms of the relevance evaluation, the draft points out that it is a very complex issue, involving many influencing factors. Registrants and notifiers should make a comprehensive analysis based on the known information, relevant knowledge and experience. At present, the relevance evaluation in China mainly follows five principles:

• Is there a reasonable time relationship between the use of a cosmetic and the occurrence of an adverse reaction?

• Is the change of an adverse reaction consistent with the discontinued use of the suspected cosmetic?

• Does the same reaction occur again when the suspected cosmetic is used again?

• Are the effects possibly caused by other factors of patients/consumers such as other diseases and other contacts excluded?

• Does the laboratory examination result indicate that the adverse reaction is related to the use of the cosmetic?

Records management is strictly regulated

In the draft, the record management of adverse reactions is strictly regulated. The records include the monitoring records and original records, and the submitted Report Form of the Cosmetic Adverse Reaction Case.

The monitoring records should be objective, authentic and accurate, and at least include the reporter’s information, the information of the person with the adverse reactions, the symptoms or signs, the severity of the adverse reactions, the occurrence date, the discovery or learning date, the reporting date, the name of the cosmetics used.

Registrants and notifiers shall number all the collected cosmetic adverse reaction reports in an exclusive, continuous and traceable way. The number shall be capable to be used in tracing back to the adverse reaction reports submitted to the national monitoring system.

Both paper records and electronic documents are acceptable. In the case of electronic documents, they shall be properly kept and appropriately backed up to avoid accidental loss or damage. Paper records shall be clear, readable, easy to understand, classified and catalogued, and subject to safety control and archiving procedures. The records shall be kept for not less than 3 years from the date of reporting.

ChemLinked expects to assist companies in applying for ingredient submission codes and registering/notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at [email protected].

Further Reading

• China Finalizes the Regulations for Cosmetic Adverse Reaction Monitoring

• China NMPA to Launch Cosmetic Adverse Reaction Monitoring System on Oct. 1

• China NMPA Clarifies Requirements for Completing Cosmetic Adverse Reaction Report