On 2022-02-21, the National Medical Products Administration issued the “Measures for the Monitoring and Administration of Adverse Reactions in Cosmetics” (hereinafter referred to as the “Measures”), which will come into force on October 1, 2022.
The monitoring of cosmetic adverse reactions is an important basis for ensuring the safety of public cosmetics. Among them, the cosmetics registrant and filing person shall assume the responsibility of monitoring the adverse reactions of the cosmetics on the market, and take effective risk control measures according to the results of analysis and evaluation. In addition, cosmetic manufacturers and operators are also obliged to monitor adverse reactions. This consolidates the main responsibility of the cosmetic registrant and filing person.
This “Measures” has 7 chapters and 47 articles, and focuses on five aspects:
01
Improve the adverse reaction monitoring system
Clarify the monitoring obligations of each parties
Establish and improve the national cosmetic adverse reaction monitoring and management system, and establish the cosmetic adverse reaction monitoring and management system. Cosmetics registrants and filing persons, responsible persons, medical institutions, and cosmetics e-commerce platform operators have clarified and refined their respective monitoring responsibilities.
02
Follow the principle of “report if suspicious”,
Improve monitoring records
Report adverse reactions of cosmetics in a true, complete and accurate manner. The registrant, filing persons, entrusted production enterprise, and medical institution shall objectively and truthfully record the activities related to adverse reaction monitoring and form monitoring records.
03
Analysis and evaluation The “adverse reaction”
Testing agency conducts follow-up investigations
to analyze and evaluate the correlation between adverse reactions and products and the severity of adverse reactions. Municipal and county-level monitoring agencies shall conduct follow-up investigations on adverse cosmetic reactions that are serious and may cause greater social impact. The national monitoring agency shall analyze and evaluate the collected adverse reactions of cosmetics across the country, and propose handling suggestions to the NMPA according to the monitoring results and the degree of risk.
04
Strengthen supervision and law enforcement
Take effective risk control measures
Carry out supervision and inspection of cosmetic registrants, filling personnel, domestic responsible persons, entrusted production enterprises, and cosmetic operators involved in adverse reactions according to their duties.
05
Clarify the main responsibilities
Strengthen the supervision of “adverse reactions”.
Cosmetics registrants, filling person, domestic responsible persons, entrusted manufacturers, cosmetics operators, and medical institutions must clarify their respective main responsibilities. The NMPA reports the annual monitoring of adverse reactions of cosmetics to the competent health department of the State Council every year.
Annex:
