Requirements for monitoring obligations of adverse reactions of cosmetic registrants and filers

Release time:

2022-09-27 09:11

On October 1, 2022, the new version of the National Cosmetic Adverse Reaction Monitoring System was put into operation, and the "Cosmetic Adverse Reaction Monitoring and Management Measures" (hereinafter referred to as the "Measures") will also be implemented simultaneously on October 1, 2022. The new version of the system has been improved in accordance with the regulations on the Supervision and Administration of Cosmetics, the measures for the Supervision and Administration of Cosmetics production and Operation, and the measures for the Monitoring and Administration of adverse reactions of Cosmetics. The approach reflects the regulatory requirements for monitoring the full life cycle safety of cosmetics. It provides for the obligations of cosmetics registrants and filers in the monitoring of adverse reactions.

Duties of 1. Cosmetics Registrant and Filing Person

Chapter II of the Measures stipulates that cosmetic registrants and filers shall establish and implement a monitoring and evaluation system for adverse reactions of cosmetics, and be equipped with institutions and personnel suitable for their products to monitor adverse reactions of cosmetics; actively collect and report adverse reactions of cosmetics to cosmetic adverse reaction monitoring institutions in accordance with the provisions of the Measures; Timely analyze and evaluate the adverse reactions of cosmetics found or learned, and take measures to control risks based on the evaluation results; cooperate with cosmetics adverse reaction monitoring institutions and departments responsible for drug supervision and administration to carry out cosmetics adverse reaction investigation.

Definition of adverse 2. reactions

Adverse reactions are defined as lesions of the skin and its appendages caused by normal use of cosmetics, as well as local or systemic damage to the human body.

Serious cosmetic adverse reactions, refers to the normal use of cosmetics caused by one of the following damage:

(I) lead to temporary or permanent loss of sexual function, affecting normal human and social functions, such as skin lesions lasting non-healing, scar formation, permanent hair loss, obvious loss of capacity changes;

(II) lead to systemic damage, such as liver and kidney dysfunction, anaphylactic shock;

(III) leads to hospitalization or medical institutions deem it necessary to be hospitalized;

(IV) cause other serious damage to the human body, endanger life or cause death.

The adverse reactions of cosmetics that may cause greater social impact refer to the adverse reactions of cosmetics that cause greater social impact or cause serious damage to many people due to the normal use of the same cosmetics in a certain area.

Contents of 3. adverse reaction monitoring

ADVERSE REACTION REPORT

The report of adverse reactions of cosmetics shall follow the principle of reporting when suspicious, and any human damage suspected of being related to the use of cosmetics shall be reported.

Cosmetic adverse reaction report should include the reporter information, adverse reaction information, adverse reaction information, the use of cosmetics information and other content.

Cosmetics registrants and filers shall publish effective contact information such as telephone numbers and electronic E-mail to the public through product labels, official websites and other methods that are convenient for consumers to learn, and actively collect reports from entrusted manufacturers, cosmetics operators, medical institutions, consumers, etc. The adverse reactions of its cosmetics on the market.

Cosmetic registrants and filers shall report adverse reactions to cosmetics through the national cosmetic adverse reaction monitoring information system after discovering or learning thereof. Adverse reactions of general cosmetics shall be reported within 30 days from the date of discovery or knowledge of adverse reactions of cosmetics, and 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. For adverse reactions and analysis and evaluation results, such as new findings or cognition, should be timely supplementary report.

The activities related to the monitoring of adverse reactions shall be truly recorded and monitoring records shall be formed, and the record retention period shall not be less than 3 years from the date of reporting. The responsible person within the territory shall assist in establishing and keeping the monitoring records of adverse reactions of cosmetics. Cosmetic adverse reaction monitoring records should at least include: reporter information, adverse reaction information, symptoms or signs, severity of adverse reactions, adverse reaction date, adverse reaction discovery or known date, adverse reaction report date, the name of the cosmetics used, etc. For cosmetics adverse reactions that are serious and may cause greater social impact, cosmetics registrants and filers should also record the causes of adverse reactions that may cause adverse reactions, analyze and evaluate the situation, and follow-up risk control measures. Medical institutions should also record the diagnosis and treatment of adverse reactions related to cosmetics.

Adverse reaction analysis and evaluation
Cosmetics registrants and filers shall analyze and evaluate the adverse reactions of cosmetics discovered or learned, and if necessary, self-examine the causes of adverse reactions that may be caused by product raw materials, formulas, production processes, production quality management, storage and transportation. The domestic responsible person shall actively assist the overseas cosmetics registrant and the filing person to analyze and evaluate the adverse reactions of cosmetics discovered or learned.

If it is a serious adverse reaction of cosmetics, the cosmetic registrant or the filing person shall, within 20 days from the date of discovery or knowledge of the adverse reaction, if it is a cosmetic adverse reaction that may cause greater social impact, it shall be analyzed and evaluated within 10 days from the date of discovery or knowledge of the adverse reaction and form a self-examination report, and submit it to the provincial monitoring institution where the cosmetic registrant, the filing person and the domestic responsible person are located, and the provincial drug administration department are located.

Adverse reaction investigation
Cosmetics registrants and filers shall immediately take measures to control the risks if they find that the products have safety risks through analysis and evaluation of adverse reactions to cosmetics. If it is found that the product has quality defects or other problems that may endanger human health, it shall, in accordance with the provisions of Article 44 of the regulations on the supervision and administration of cosmetics, immediately stop production, recall the cosmetics that have been put on the market, and notify the relevant cosmetics operators and consumers to stop operation and use. Domestic responsible persons shall actively assist overseas cosmetic registrants and filers in taking measures to control risks.

In addition, cosmetics registrants and filers need to cooperate with drug supervision and administration departments to carry out adverse reaction analysis, evaluation and self-examination.

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