Attachment details

Management measures for monitoring adverse reactions of cosmetics

Chapter I total be

Article 1  To strengthen the monitoring of adverse reactions of cosmetics,Timely and effectively control the safety risks of cosmetics,Protect consumer health,basis Regulations on the supervision and administration of cosmetics Measures for the supervision and administration of the production and operation of cosmetics Other regulations rules,These measures are formulated.

Article 2  To monitor and supervise the adverse reactions of cosmetics within the territory of the people's Republic of China,These Measures shall apply.

Article 3  The State Drug Administration is responsible for the national monitoring and management of adverse reactions to cosmetics.The drug supervision and administration departments of the local people's governments at or above the county level shall be responsible for the monitoring and administration of adverse reactions of cosmetics in their respective administrative areas.

The Department in charge of drug supervision and administration of the local people's government at or above the county level shall specify the monitoring organization for adverse reactions of cosmetics,To be responsible for the monitoring technology of adverse reactions of cosmetics in the administrative region.

Article 4  Cosmetic registrant The filer shall establish a monitoring and evaluation system for adverse reactions of cosmetics,Actively collect the adverse reactions of cosmetics on the market,Carry out analysis and evaluation in time,And report to the adverse reaction monitoring organization of cosmetics in accordance with the provisions of these measures,Implement the main responsibility of cosmetics quality and safety.Entrusted production enterprise Adverse reactions that may be related to the use of cosmetics found by cosmetics operators and medical institutions,It shall report to the adverse reaction monitoring agency of cosmetics in accordance with the provisions of these measures.

Article 5  The State encourages other units and individuals to report adverse reactions that may be related to the use of cosmetics to the cosmetics adverse reaction monitoring agency or the Department in charge of drug supervision and administration,Give full play to the role of social supervision,Promote the safe and social co governance of cosmetics.

Article 6  The State Drug Administration is responsible for establishing the national adverse reaction monitoring information system of cosmetics,Strengthen the information construction of adverse reaction monitoring of cosmetics.

Chapter II Responsibilities and obligations

Article 7  The State Drug Administration is responsible for the national monitoring and management of adverse reactions to cosmetics,Perform the following main responsibilities

one Establish and improve the national cosmetics adverse reaction monitoring and management system,Organize the formulation of adverse reaction monitoring and management system of cosmetics,And supervise the implementation

two Organize the investigation of cosmetic adverse reactions that may cause great social impact,Take control measures according to law

three Organize, supervise and inspect the monitoring of adverse reactions of cosmetics

four Formulate and release the national cosmetics adverse reaction monitoring and evaluation base Hereinafter referred to as national monitoring base Identification standards and management specifications,And organize selection Management of national monitoring base

five Organize and carry out national cosmetics adverse reaction monitoring and publicity train Research and international exchange.

Article 8  province Autonomous Region Drug regulatory departments of municipalities directly under the central government Hereinafter referred to as the provincial drug administration department Be responsible for the monitoring and management of adverse reactions of cosmetics in the administrative region,Perform the following main responsibilities

one Establish and improve the monitoring and management system of adverse reactions of cosmetics in this administrative region,Provide institutions and personnel suitable for monitoring,Improve the working system and supervise the implementation

two Organize to investigate the serious adverse reactions of cosmetics that occur in the administrative area and may cause great social impact,Take control measures according to law

three Organize the supervision and inspection of the monitoring of adverse reactions of cosmetics in their respective administrative areas

four Organize the monitoring and publicity of adverse reactions of cosmetics in the administrative region train Research and other work.

Article 9  Municipal level divided into districts County level department in charge of drug supervision and Administration Hereinafter referred to as the municipal and county-level supervision department To be responsible for the monitoring and management of adverse reactions of cosmetics in the administrative region,Perform the following main responsibilities

one Establish and improve the monitoring and management system of adverse reactions of cosmetics in this administrative region,Provide institutions and personnel suitable for monitoring,Improve the working system and supervise the implementation

two Investigate the serious adverse reactions of cosmetics that occur in the administrative area and may cause great social impact,According to the monitoring results and work needs,Investigate other adverse reactions of cosmetics in the administrative area,Take control measures according to law

three Monitoring of adverse reactions of cosmetics in the region

four Organize the monitoring and publicity of adverse reactions of cosmetics in the administrative region train Research and other work.

Article 10  National cosmetics adverse reaction monitoring agency Hereinafter referred to as the national monitoring agency To be responsible for the national monitoring technology of adverse reactions of cosmetics,Perform the following main responsibilities

one collect Analysis and evaluation of adverse reactions of cosmetics in China,And put forward risk management suggestions to the State Drug Administration

two Adverse reactions to cosmetics that may cause great social impact,Put forward handling suggestions to the State Drug Administration and cooperate with the investigation

three Be responsible for the construction and maintenance of the national adverse reaction monitoring information system of cosmetics

four Formulate technical standards and specifications for monitoring adverse reactions of cosmetics,Provide operational guidance to local monitoring institutions at all levels and national monitoring bases

five Carry out national monitoring and publicity of adverse reactions of cosmetics train Research and international exchange.

Article 11  Provincial cosmetics adverse reaction monitoring organization Hereinafter referred to as provincial monitoring organization To be responsible for the monitoring technology of adverse reactions of cosmetics in the administrative region,Perform the following main responsibilities

one collect Analyze and evaluate the adverse reactions of cosmetics in the administrative area,And put forward risk management suggestions to the local provincial drug administration department

two Adverse reactions to cosmetics that are serious and may cause great social impact within the administrative area,Put forward handling suggestions to the local provincial drug administration department and cooperate with the investigation

three To be responsible for the use and management of the national cosmetics adverse reaction monitoring information system in their respective administrative regions

four Monitoring institutions for adverse reactions of cosmetics at the municipal and county levels divided into districts Hereinafter referred to as the municipal and county-level monitoring institutions Conduct business guidance,Organize the registration of cosmetics within the administrative region Filing person Domestic responsible person Entrusted production enterprise Cosmetics operator Provide technical guidance to medical institutions, etc

five Carry out the monitoring and publicity of adverse reactions of cosmetics in this administrative region train Research and other work.

Article 12  The municipal and county level monitoring institutions are responsible for the monitoring technology of adverse reactions of cosmetics in their respective administrative areas,Perform the following main responsibilities

one collect Analyze and evaluate the adverse reactions of cosmetics in the administrative area,And put forward risk management suggestions to the local department responsible for drug supervision and administration at the same level

two Adverse reactions to cosmetics that are serious and may cause great social impact within the administrative area,Put forward handling suggestions to the local department responsible for drug supervision and administration at the same level and cooperate with the investigation.According to the monitoring results and risk degree,For other adverse reactions of cosmetics in the administrative area, put forward treatment suggestions to the local department responsible for drug supervision and administration at the same level and cooperate with the investigation

three Assist provincial monitoring institutions to carry out the technical work of monitoring adverse reactions of cosmetics

four For the registrants of cosmetics within the Administrative Region Filing person Domestic responsible person Entrusted production enterprise Cosmetics operator Provide technical guidance to medical institutions, etc

five Carry out the monitoring and publicity of adverse reactions of cosmetics in this administrative region train Research and other work.

Article 13  Cosmetic registrant The filing person shall have the ability to carry out the monitoring of adverse reactions of cosmetics,Perform the following obligations in accordance with the regulations on the supervision and administration of cosmetics

one Establish and implement the monitoring and evaluation system of adverse reactions of cosmetics,Allocate institutions and personnel suitable for their products to monitor adverse reactions of cosmetics

two Actively collect and report adverse reactions of cosmetics to the adverse reaction monitoring organization of cosmetics in accordance with the provisions of these measures

three Timely analyze and evaluate the adverse reactions of cosmetics found or learned,Take measures to control risks according to the evaluation results

four Cooperate with cosmetic adverse reaction monitoring organization The Department in charge of drug supervision and administration shall carry out the investigation of adverse reactions of cosmetics.

Overseas cosmetics registrant The filing person shall establish an active collection system for adverse reactions with the domestic responsible person report Assistance mechanism for analysis, evaluation, investigation and handling,Ensure the performance of the obligations under paragraph 1 of this article.

Article 14  Entrusted production enterprise Cosmetic operators shall report the adverse reactions of cosmetics found or learned to the adverse reaction monitoring agency of cosmetics in accordance with the regulations on the supervision and administration of cosmetics and these measures,And cooperate with the cosmetics adverse reaction monitoring organization The Department in charge of drug supervision and administration shall carry out the investigation of adverse reactions of cosmetics.

Article 15  Medical institutions shall, in accordance with the provisions of the regulations on the supervision and administration of cosmetics and these measures, report the adverse reactions of cosmetics found or learned to the adverse reaction monitoring institution of cosmetics,And cooperate with the cosmetics adverse reaction monitoring organization The Department in charge of drug supervision and administration shall carry out the investigation of adverse reactions of cosmetics.

Specialized medical institutions for dermatology A secondary or higher medical institution with dermatology department shall establish a cosmetic adverse reaction monitoring system suitable for its diagnosis and treatment scope,And ensure the effective implementation of the monitoring system.

Article 16  The operators of cosmetics e-commerce platform are informed of the adverse reactions of cosmetics,It shall be recorded and timely handed over to the cosmetics operators in the platform for disposal,Urge the cosmetics operators in the platform to fulfill the adverse reaction reporting obligations of cosmetics operators,Cooperate with cosmetic adverse reaction monitoring organization The Department in charge of drug supervision and administration shall carry out the investigation of adverse reactions of cosmetics.

Article 17  The national monitoring base shall provide technical support for the monitoring of adverse reactions of cosmetics in accordance with the requirements of management norms,Participate in the analysis and evaluation of cosmetic adverse reactions that are serious and may cause great social impact by drug regulatory departments and monitoring institutions above the provincial level,Assist in the monitoring and publicity of adverse reactions of cosmetics train Research Technical guidance and other work.

Chapter III  Adverse reaction report

Article 18  The reporting of adverse reactions of cosmetics shall follow the principle of reporting suspicious immediately,Suspected human damage related to the use of cosmetics,Should be reported.

The contents of reporting adverse reactions of cosmetics shall be true complete accuracy.The adverse reaction report of cosmetics shall include the information of the reporter Information of adverse reactions Adverse reaction information Cosmetics information used.

Article 19  Cosmetic registrant The filing person shall pass the product label The official website and other ways to facilitate consumers to know the telephone number to the public E-mail and other effective contact information,Actively collect information from entrusted production enterprises Cosmetics operator medical institution Adverse reactions of cosmetics on the market reported by consumers.

Cosmetic registrant After discovering or knowing the adverse reactions of cosmetics, the filer shall report through the national adverse reaction monitoring information system of cosmetics.

Article 20  Entrusted production enterprise Cosmetics operator After the medical institution discovers or learns the adverse reactions of cosmetics,It should be reported through the national cosmetics adverse reaction monitoring information system,Encourage them to inform the cosmetic registrant Filing person.

Cosmetics operators and medical institutions that do not have online reporting conditions for the time being,It shall report to the local monitoring institution at the city and county level through paper statements,Submit the report online on its behalf.

Article 21  The operators of cosmetics e-commerce platform are informed of the adverse reactions of cosmetics,Reporter information should be recorded Information of adverse reactions Adverse reaction information Cosmetics information used,And in7Within days, it shall be handed over to the cosmetics operators on the platform for treatment.Involving production,s%s,s%s s%s s%s s%s s%s s%s15s%s.

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