On January 4, the Cosmetics Supervision and Administration Bureau of the State Food and Drug Administration issued a letter on publicly soliciting opinions on the "Administrative Measures for Cosmetics Registration and Filing Inspection (Draft for Solicitation of Comments)", which will replace the original issued by the State Food and Drug Administration after implementation. "Administrative Measures for the Administration of Cosmetics Administrative Licensing Inspection" (National Food and Drug Administration  No. 82) and "Administrative Measures for the Qualification Accreditation of Cosmetics Administrative Licensing Inspection Institutions" (National Food and Drug Administration  No. 83). The following is the original opinion draft:
Cosmetics Registration and Filing Inspection Management Measures (Draft for Solicitation of Comments)
Chapter 1 General
Article 1 In order to standardize the registration and filing inspection of cosmetics, and to ensure that the registration and filing inspection of cosmetics are open, fair, just, and scientific, these measures are formulated in accordance with the relevant regulations of cosmetics.
Article 2 These Measures are applicable to the supervision and management of cosmetics registration and filing inspection within the territory of the People's Republic of China.
Article 3 The cosmetics registration and filing inspection mentioned in these Measures means that the cosmetics manufacturer entrusts the cosmetics inspection agency to check the safety and compliance of the product before the product or new raw material (hereinafter collectively referred to as the "product") applies for registration and filing. The process of conducting inspections and issuing inspection reports by the inspection agency. The inspection agency (hereinafter referred to as the inspection agency) that is responsible for cosmetics registration and filing inspection shall file with the State Drug Administration for filing.
Article 4 The State Drug Administration shall organize the establishment of a cosmetics registration and filing inspection management information system (hereinafter referred to as the inspection information system) for the filing management of inspection institutions, cosmetics registration and filing inspection management.
Article 5 The inspection agency engaged in registration and filing inspection work shall respect science, abide by professional ethics, and issue inspection reports that shall be objective, fair and accurate. The inspection agency is responsible for the inspection report issued by it and bears corresponding legal responsibilities.
Article 6 A cosmetics manufacturer shall be responsible for the authenticity, completeness and traceability of the samples and materials provided in the process of registration and filing inspection, and bear corresponding legal responsibilities.
Chapter II Filing Management of Inspection Institutions
Article 7 The inspection agency shall have the qualification of an independent legal person and obtain the certification of inspection and testing qualification (CMA), and the scope of the certification of inspection and testing qualification (CMA) obtained can meet the needs of cosmetic registration or filing inspection. The human body safety and efficacy inspection agency should also set up an ethics committee, establish a volunteer management and adverse reaction handling system, and personnel engaged in clinical evaluation should have the qualifications of practicing physicians and have more than five years of relevant work experience.
When applying for filing, the inspection agency should have more than three years of experience in cosmetics inspection related work, and there should be no violations of laws and regulations and no major business accidents in the past three years.
Article 8 The inspection agency shall conduct corresponding filing through the inspection information system based on its own inspection capability conditions. The inspection agency shall submit the following information for record:
(1) The organization's name, nature, address, contact information, scale profile and legal person qualification certification documents;
(2) The relevant statutory qualifications or conditions for cosmetics inspection and testing already possessed;
(3) Cosmetic inspection work items that can be carried out according to qualifications or conditions, and the estimated number of samples that can be inspected;
(4) The quality management system and its operation, including management system documents related to cosmetics registration and filing inspection;
(5) Overview of the cosmetics inspection team;
(6) List of main instruments and equipment, facilities and description of environmental conditions;
(7) Past inspections of cosmetics;
(8) An explanation of no violation of laws or regulations and no major business accidents in the past three years;
(9) Emergency response to prevent and handle emergencies and serious adverse events in cosmetics inspection work;
(10) Other situations that need to be explained.
The inspection agency shall bear legal responsibility for the authenticity and accuracy of the information on record.
Article 9 Inspection institutions are divided into microbiological and physical and chemical tests, toxicological tests, human safety and efficacy tests, etc. according to their different test capabilities.
The inspection agency shall select one or more modules for the inspection agency filing based on the project content of the CMA that has been obtained, and submit the corresponding filing materials.
Article 10 The registered inspection agency shall issue the account and password of the working user by the inspection information system, and undertake the inspection work entrusted by the cosmetics manufacturer.
For the registered inspection agency, its name, address, contact information, scope of inspection items, and certification of cosmetics inspection qualifications it has obtained shall be announced to the public by the State Drug Administration through its website.
Article 11 A registered inspection agency shall make changes to the record information through the inspection information system in a timely manner when there is a change in the relevant information filed.
When the inspection agency no longer has the corresponding capabilities and conditions to undertake cosmetics registration and filing inspection, or no longer continues to engage in cosmetics registration and filing inspection, it shall take the initiative to cancel its filing information.
Chapter III Registration and Filing Inspection Management
Article 12 A cosmetics manufacturer shall, in accordance with the requirements for cosmetic registration and filing inspection items (Annex 1), select a filing inspection agency to carry out corresponding product entrusted inspections.
The registration and filing inspection of the same product shall be independently completed by the same inspection agency and an inspection report shall be issued. If it involves human safety and efficacy testing, another testing agency with corresponding capabilities may be selected to undertake it.
Article 13 A cosmetics manufacturer shall submit an application for entrusted inspection to an inspection agency that meets the requirements of product inspection items through the inspection information system, fill in the corresponding entrusted inspection product information, and submit the product instruction manual and other materials.
After the inspection agency accepts the entrusted inspection application, if the cosmetics manufacturer really needs to change the company's name, address and other relevant information, it can submit a change application through the inspection information system. Once the product formula is submitted, it cannot be changed.
Article 14 A cosmetics manufacturer shall provide all samples required for product inspection to the first inspection agency (hereinafter referred to as the first inspection agency) that accepts registration and filing inspection applications at one time. The samples submitted for inspection should be commercial samples of the same batch number with complete packaging and unopened seals. Domestic special-purpose cosmetics can be trial-produced samples. If the final product may affect the inspection result due to packaging reasons (such as spray products, air cushion products, etc.), the manufacturer shall cooperate in providing semi-finished products for the last process before packaging, and the inspection agency shall explain it in the inspection report.
The remaining shelf life of the samples when submitted for inspection shall not be less than half of the product shelf life.
Article 15 The first inspection agency is responsible for sealing samples of the same name and batch number that need to be sent to other inspection agencies or for product registration and filing, and attach relevant materials such as inspection application and acceptance decision.
Article 16 The inspection agency shall conduct inspections in accordance with the requirements of these Measures, and the inspection methods shall comply with the requirements of relevant national laws, regulations and standards.
Article 17 In the inspection report issued by the inspection agency, the inspection results shall be true and accurate; the original inspection records shall be true, standardized and complete, and shall be kept in accordance with relevant regulations. The inspection agency shall upload the inspection report to the inspection information system and enter the inspection result at the same time.
Article 18 The retention period of samples shall be 24 months from the date of issuance of the inspection report or until the expiration of the shelf life and expiration date of the samples. The samples that exceed the retention period shall be destroyed by themselves after being approved by the person in charge of the registration and filing inspection agency in accordance with the prescribed procedures, and shall not pollute the environment during disposal. There should be detailed records on the disposal of the retained samples.
In the process of cosmetics registration and filing, if the drug regulatory authority responsible for registration and filing finds that there is a problem with the inspection report that requires experimental review, the inspection agency that retains the sample shall cooperate in calling the retained sample.
Article 19 The inspection agency shall issue a product inspection report in accordance with the requirements and style of cosmetics registration and filing inspection reports (Annex 2).
The inspection report shall be in triplicate, one copy shall be kept by the inspection agency, and the second copy shall be submitted to the enterprise applying for entrusted inspection.
The change of the inspection report shall be implemented in accordance with the relevant regulations of China Metrology Certification/ Accreditation (CMA).
Article 20 The inspection agency shall properly keep the inspection report and related materials in accordance with regulations.
The retention period of the registration and filing inspection files shall be no less than six years.
The registration and filing inspection files should at least include registration and filing inspection application and acceptance related materials, inspection sample handover and inspection process records, inspection original records, inspection reports, and the instructions submitted by the applicant enterprise, etc., which are related to the product registration and filing inspection. Related information, etc.
Article 21 The inspection agency shall establish a management system and continue to operate effectively, formulate a sound management system, standardize the cosmetics registration and filing inspection workflow and business documents, and ensure that the inspection agency's operation meets the requirements of registration and filing inspection.
The inspection agency shall establish a personnel qualification review, training and assessment system to ensure that the personnel qualifications and abilities meet the requirements of cosmetics registration and filing inspection.
The inspection agency shall ensure that the conditions of equipment and environmental facilities meet the requirements of cosmetics registration and filing inspection.
Article 22 Inspection institutions and their staff shall, in accordance with laws and regulations, perform the obligation to keep confidential the state secrets, commercial secrets, technical secrets or other related information that they learn during the registration and filing inspection.
Article 23 The inspection agency shall establish an appeal and complaint handling system, promptly handle objections and complaints about cosmetics registration and filing inspection, and keep records.
Chapter IV Supervision and Inspection
Article 24 The drug supervision and administration department is responsible for organizing the daily supervision and inspection of the inspection agency, due-for-factor inspection, unannounced inspection, and ability assessment.
The inspection agency shall cooperate with the supervision and inspection work carried out by the drug regulatory authority.
Article 25 The provincial drug supervision and administration department shall organize the supervision and inspection and special on-site supervision and inspection of the registration and filing inspection of inspection institutions within its administrative area. The main inspection contents include:
(1) The authenticity of the information filed by the inspection agency;
(2) Standardization of inspection work;
(3) Check the authenticity of the data;
(4) The retention and archiving of inspection data and materials;
(5) The situation of sample collection, sample sealing, inspection and retention.
Article 26 If the drug regulatory department discovers problems in product inspection during the process of product registration and filing, it may organize the inspection of the inspection agency that issued the report for a reason.
Article 27 According to actual needs, the State Drug Administration shall organize unannounced inspections and capability assessments of inspection institutions.
The drug inspection agency of the national drug regulatory authority cooperates with the national drug regulatory authority to study and formulate relevant work plans such as cause inspection, unannounced inspection and ability assessment, and organize the implementation.
Article 28: If an inspection institution has any of the following circumstances, the drug regulatory authority shall urge the inspection institution to make rectification. If rectification is not made within the time limit or the requirements are still not met after rectification, the drug regulatory authority will no longer accept cosmetic registration or filing inspection reports issued by the inspection agency:
(1) Irregularities in the acceptance procedures for registration and filing inspection;
(2) The registration and filing inspection reports do not meet the prescribed requirements;
(3) The registration and filing inspection records, sample retention and inspection file data preservation do not meet the requirements;
(4) Errors occurred in the process of registration and filing inspection;
(5) Misreporting or failing to report the information recorded by the inspection agency, or failing to update the information truthfully in the inspection information system in a timely manner after the information is changed;
(6) Issuing an inspection report beyond the inspection scope filed in the inspection information system;
(7) The results of participating in the ability assessment fail to meet the requirements;
(8) Other circumstances that violate the requirements of these Measures.
Article 29 If an inspection agency has one of the following circumstances, the drug regulatory authority will cancel the inspection agency’s filing and no longer accept the cosmetics registration or filing inspection report issued by the inspection agency; if the inspection agency is suspected of violating relevant laws and regulations, Transfer to relevant departments for investigation and punishment according to law; if a crime is constituted, transfer to judicial organs for investigation of criminal responsibility according to law:
(1) Falsely reporting or concealing the filing information of the inspection agency;
(2) The inspection process and results are falsified;
(3) Issuing or forging false inspection reports or inspection records;
(4) Failure to participate in the ability assessment as required without special reasons;
(5) Failure to cooperate with supervision and inspection;
(6) Subcontracting inspection items in violation of regulations;
(7) When the inspection agency no longer has the corresponding ability and conditions to undertake cosmetics registration and filing inspection, or does not continue to engage in cosmetics registration and filing inspection, it does not take the initiative to cancel the filing information of the inspection agency.
Article 30: Any unit or individual has the right to report violations of laws and regulations in the inspection work of inspection institutions to the State Drug Administration, and the State Drug Administration shall investigate and deal with it in a timely manner, and keep the reporter confidential.
Article 31 The State Drug Supervision and Administration Department shall promptly notify the public of the supervision and inspection status of the registration and filing inspection institutions.
Chapter V Supplementary Provisions
Article 32 The cosmetics production enterprises mentioned in these Measures include the entrusted production enterprises of cosmetics and the actual production enterprises of cosmetics.
The competence assessment referred to in these Measures refers to the use of inter-laboratory comparisons, measurement audits, and sample retention retests to assess and evaluate the capabilities of inspection institutions in accordance with pre-established guidelines.
Article 33: The National Drug Administration is responsible for the interpretation of these Measures. The State Drug Administration may add new inspection items or methods according to the needs of cosmetic safety inspection work, and announce them in time.
Article 34 These Measures shall come into force on the day of 20 × × year × × month × ×. The "Administrative Measures for the Inspection of Cosmetics Administrative Licensing" issued by the former State Food and Drug Administration (National Food and Drug Administration  No. 82) and the "Administrative Measures for the Qualification of Cosmetic Administrative Licensing Inspection Institutions" (National Food and Drug Administration  83) at the same time abolished.
(Source: Cosmetics Supervision and Administration Bureau of the State Drug Administration)