Forward | Measures for the Management of Cosmetic Registration and Filing Inspections of the National Medical Products Administration (Draft for Comments)

On January 4, the Cosmetics Supervision and Administration Department of the National Medical Products Administration issued a letter on publicly soliciting opinions on the "Measures for the Administration of Cosmetic Registration and Filing Inspections (Draft for Comment)". After its implementation, this measure will replace the "Measures for the Administration of Cosmetic Administrative Licensing Inspections" (国食药监许〔2010〕82号) and the "Measures for the Administration of Qualification Accreditation for Cosmetic Administrative Licensing Inspection Agencies" (国食药监许〔2010〕83号) issued by the former State Food and Drug Administration. The original text of the draft for comment is as follows:

Measures for the Administration of Cosmetic Registration and Filing Inspections (Draft for Comment)

Chapter 1 General Provisions

Article 1 These Measures are formulated in accordance with relevant laws and regulations on cosmetics to regulate cosmetic registration and filing inspection work and to ensure that such work is open, fair, just, and scientific.

Article 2 These Measures apply to the supervision and administration of cosmetic registration and filing inspection activities carried out within the territory of the People's Republic of China.

Article 3 For the purpose of these Measures, cosmetic registration and filing inspection refers to the process by which cosmetic manufacturers, prior to applying for registration and filing of products or new raw materials (hereinafter collectively referred to as "products"), entrust cosmetic inspection agencies to inspect the safety and compliance of the products, and by which the inspection agencies issue inspection reports. Inspection agencies undertaking cosmetic registration and filing inspections (hereinafter referred to as "inspection agencies") shall file with the national medical products administration department.

Article 4 The national medical products administration department shall organize the establishment of a cosmetic registration and filing inspection management information system (hereinafter referred to as the "inspection information system") for the filing management of inspection agencies and the management of cosmetic registration and filing inspections.

Article 5 Inspection agencies engaged in registration and filing inspection work shall respect science, abide by professional ethics, and ensure that the inspection reports issued are objective, fair, and accurate. Inspection agencies shall be responsible for the inspection reports they issue and bear corresponding legal liabilities.

Article 6 Cosmetic manufacturers shall be responsible for the authenticity, completeness, and traceability of the samples and materials provided during the registration and filing inspection process and shall bear corresponding legal liabilities.

Chapter 2 Inspection Agency Filing Management

Article 7 Inspection agencies shall possess independent legal person qualifications and obtain inspection and testing accreditation (CMA), and the scope of their inspection and testing accreditation (CMA) shall meet the needs of cosmetic registration or filing inspection work. Inspection agencies for human safety and efficacy shall also establish ethics committees, build volunteer management and adverse reaction disposal systems, and personnel engaged in clinical evaluation work shall possess practitioner physician qualifications and have more than five years of relevant work experience.

When applying for filing, inspection agencies shall have more than three years of experience in cosmetic inspection-related work, and in the past three years, there should be no illegal or non-compliant behaviors and no major business accidents.

Article 8 Inspection agencies shall carry out corresponding filing through the inspection information system based on their own inspection capabilities and conditions. Inspection agencies shall submit the following information for filing:

(1) Name, nature, address, contact information, general scale, and legal person qualification documents of the agency;

(2) Relevant legal qualifications or conditions already possessed for cosmetic inspection and testing work;

(3) Cosmetic inspection projects that can be carried out based on qualifications or conditions, and the estimated number of samples that can be undertaken for inspection;

(4) Quality management system and its operation, including management system documents related to cosmetic registration and filing inspection;

(5) Overview of the cosmetic inspection work team;

(6) List of main instruments, equipment, facilities, and description of environmental conditions;

(7) Past experience in carrying out cosmetic inspection work;

(8) Statement of no illegal or non-compliant behaviors and no major business accidents in the past three years;

(9) Emergency response measures for preventing and handling sudden incidents and serious adverse events in cosmetic inspection work;

(10) Other circumstances requiring explanation.

Inspection agencies shall bear legal responsibility for the authenticity and accuracy of the filing information.

Article 9 Inspection agencies are divided into modules such as microbiological and physicochemical inspection, toxicology testing, human safety, and efficacy inspection, according to their different inspection capabilities.

Inspection agencies shall select one or more modules for inspection agency filing based on the content of the accreditation (CMA) projects already obtained, and submit corresponding filing materials.

Article 10 For filed inspection agencies, the inspection information system shall issue work user accounts and passwords, and these agencies shall undertake inspection work entrusted by cosmetic manufacturers.

Information about filed inspection agencies, such as their agency name, address, contact information, scope of inspection items, and obtained cosmetic inspection qualifications, shall be publicly disclosed by the national medical products administration department through its website.

Article 11 When there are changes to the relevant filing information of a filed inspection agency, it shall promptly make changes to the filing information through the inspection information system.

When an inspection agency no longer possesses the corresponding capabilities and conditions to undertake cosmetic registration and filing inspection work, or no longer continues to engage in cosmetic registration and filing inspection work, it shall proactively cancel its filing information.

Chapter 3 Registration and Filing Inspection Management

Article 12 Cosmetic manufacturers shall select a filed inspection agency to carry out entrusted product inspections in accordance with the requirements for cosmetic registration and filing inspection items (Annex 1).

The registration and filing inspection of the same product shall be independently completed and reported by the same inspection agency. If human safety and efficacy inspections are involved, another inspection agency with corresponding capabilities may be selected to undertake them.

Article 13 Cosmetic manufacturers shall submit applications for entrusted inspections to inspection agencies that meet the product inspection item requirements through the inspection information system, fill in the corresponding entrusted inspection product information, and simultaneously submit materials such as product instructions.

After an inspection agency accepts an entrusted inspection application, if a cosmetic manufacturer indeed needs to change relevant information such as the company name or address, they may submit a change application through the inspection information system. Once the product formula is submitted, it shall not be changed.

Article 14 Cosmetic manufacturers shall provide all samples required for product inspection at one time to the first inspection agency accepting registration and filing inspection applications (hereinafter referred to as the first inspection agency). The samples submitted for inspection shall be commercial samples of the same batch number, complete in packaging and unopened; for domestic special-purpose cosmetics, trial samples may be provided. If the final product's packaging may affect the inspection results (e.g., spray products, cushion products, etc.), the manufacturer should cooperate by providing semi-finished products from the last process before packaging, and the testing agency shall state this in the inspection report.

The remaining shelf life of samples submitted for inspection shall not be less than half of the product's 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 submitted for product registration and filing, and attaching relevant documents such as inspection applications and acceptance decisions.

Article 16 Inspection agencies 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 standard specifications.

Article 17 The inspection reports issued by inspection agencies shall have truthful and accurate inspection results; original inspection records shall be truthful, standardized, and complete, and preserved in accordance with relevant regulations. Inspection agencies shall upload inspection reports to the inspection information system and simultaneously enter inspection results.

Article 18 The retention period for samples shall be 24 months from the date of issuing the inspection report or until the end of the sample's shelf life or limited use date. Samples exceeding the retention period shall be self-destroyed in accordance with prescribed procedures after approval by the person in charge of the registration and filing inspection agency, and the disposal shall not pollute the environment. The disposal of retained samples shall be detailed in records.

During the process of cosmetic registration and filing, if the drug regulatory department responsible for registration and filing finds issues with an inspection report that require experimental re-verification, the inspection agency retaining the samples shall cooperate by recalling the retained samples.

Article 19 Inspection agencies shall issue product inspection reports in accordance with the requirements and format for cosmetic registration and filing inspection reports (Annex 2).

Inspection reports shall be issued in triplicate: one copy for retention by the inspection agency, and two copies for the enterprise applying for commissioned inspection.

Changes to inspection reports shall be executed in accordance with the relevant provisions of China Metrology Accreditation/Certification (CMA).

Article 20 Inspection agencies shall properly preserve inspection reports and related documents as required.

The retention period for registration and filing inspection archives shall be no less than six years.

Registration and filing inspection archives shall at least include relevant materials for registration and filing inspection applications and acceptance, records of inspection sample handover and inspection procedures, original inspection records, inspection reports, and other materials related to the product's registration and filing inspection, such as user manuals submitted by the applicant enterprise.

Article 21 Inspection agencies shall establish and continuously operate a management system, formulate sound management procedures, standardize cosmetic registration and filing inspection workflows and business documents, and ensure that the inspection agency's operations comply with the requirements for registration and filing inspection work.

Inspection agencies shall establish systems for personnel qualification review, training, and assessment to ensure that personnel qualifications and capabilities meet the requirements for cosmetic registration and filing inspection work.

Inspection agencies shall ensure that instrument equipment and environmental facility conditions meet the needs of cosmetic registration and filing inspection work.

Article 22 Inspection agencies and their staff shall, in accordance with laws and regulations, fulfill confidentiality obligations regarding national secrets, commercial secrets, technical secrets, or other relevant information learned during registration and filing inspection work.

Article 23 Inspection agencies shall establish a system for handling appeals and complaints, promptly address objections and complaints regarding cosmetic registration and filing inspection work, and maintain records.

Chapter 4 Supervision and Inspection

Article 24 The drug regulatory department is responsible for organizing routine supervision and inspection, for-cause verification, unannounced inspections, and capability assessments of inspection agencies.

Inspection agencies shall cooperate with the supervision and inspection work carried out by the drug regulatory department.

Article 25 Provincial drug regulatory departments shall organize supervision and inspection and special on-site supervision and verification of the registration and filing inspection work of inspection agencies within their administrative areas. The main inspection contents include:

(1) Authenticity of inspection agency filing information;

(2) Regularity of inspection work;

(3) Authenticity of inspection data;

(4) Retention and archiving of inspection data and documents;

(5) Sample collection, sealing, inspection, and retention status.

Article 26 If the drug regulatory department finds issues with product inspection during the product registration and filing process, it may organize for-cause verification of the inspection agency that issued the report.

Article 27 The National Medical Products Administration shall organize unannounced inspections and capability assessments of inspection agencies based on actual needs.

The drug inspection agencies under the National Medical Products Administration shall cooperate with the National Medical Products Administration in researching and formulating relevant work plans for for-cause inspections, unannounced inspections, and capability assessments, and organize their implementation.

Article 28 If an inspection agency has one of the following circumstances, the drug regulatory department shall urge the inspection agency to rectify. If rectification is not completed within the deadline or still does not meet the requirements after rectification, the drug regulatory department will no longer accept cosmetic registration or filing inspection reports issued by the inspection agency:

(1) Irregular registration and filing inspection acceptance procedures;

(2) Registration and filing inspection reports that do not meet prescribed requirements;

(3) Registration and filing inspection records, sample retention, and inspection archive preservation that do not meet requirements;

(4) Errors occurring during the registration and filing inspection process;

(5) Misreporting or omitting inspection agency filing information, or failing to promptly and truthfully update information in the inspection information system as required after changes occur;

(6) Issuing inspection reports beyond the scope of inspection filed in the inspection information system;

(7) Participating in capability assessments with unsatisfactory results;

(8) Other circumstances that violate the requirements of these Measures.

Article 29   If a testing institution has any of the following circumstances, the drug regulatory department shall cancel its filing and no longer accept cosmetic registration or filing inspection reports issued by it; if the testing institution is suspected of violating relevant laws and regulations, it shall be transferred to the relevant departments for investigation and handling in accordance with the law; if a crime is constituted, it shall be transferred to judicial organs to pursue criminal responsibility in accordance with the law:

(1) Falsely reporting or concealing filing information of the testing institution;

(2) Falsifying inspection processes and results;

(3) Issuing or fabricating false inspection reports or inspection records and other materials;

(4) Failing to participate in proficiency testing as required without special reasons;

(5) Failing to cooperate with supervision and inspection;

(6) Subcontracting inspection items in violation of regulations;

(7) When the testing institution no longer possesses the corresponding capabilities and conditions to undertake cosmetic registration and filing inspection work, or no longer continues to engage in cosmetic registration and filing inspection work, failing to voluntarily cancel the filing information of the testing institution.

Article 30   Any unit or individual has the right to report illegal or non-compliant acts in the inspection work of testing institutions to the National Medical Products Administration. The National Medical Products Administration shall promptly investigate and handle such reports and keep the identity of the informant confidential.

Article 31   The National Medical Products Administration shall promptly inform the public of the supervision and inspection status of registered and filed testing institutions.

Chapter 5   Supplementary Provisions

Article 32   The term "cosmetic production enterprise" as used in these Measures includes entrusted cosmetic production enterprises and actual cosmetic production enterprises.

The term "proficiency testing" as used in these Measures refers to the assessment and evaluation of the capabilities of testing institutions through inter-laboratory comparisons, measurement audits, retesting of retained samples, and other methods, in accordance with pre-established criteria.

Article 33   These Measures shall be interpreted by the National Medical Products Administration. The National Medical Products Administration may add new inspection items or methods as required by cosmetic safety inspection work and promptly announce them.

Article 34   These Measures shall come into force on ××/××/20××. The "Measures for the Administration of Cosmetic Administrative Licensing Inspection" (Guo Shi Yao Jian Xu [2010] No. 82) and the "Measures for the Administration of Qualification Accreditation of Cosmetic Administrative Licensing Inspection Institutions" (Guo Shi Yao Jian Xu [2010] No. 83) issued by the former State Food and Drug Administration shall be repealed simultaneously.

(Source: National Medical Products Administration, Cosmetics Supervision Department)