Measures for the Administration of Cosmetic Inspections

Chapter I: General Provisions

Article 1 These Measures are formulated in accordance with regulations and rules such as the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Administration of Cosmetic Registration and Filing, and the Measures for the Supervision and Administration of Cosmetic Production and Business Operation, in order to standardize cosmetic inspection work.

Article 2 These Measures apply to inspections conducted by departments responsible for drug supervision and administration (hereinafter referred to as drug regulatory departments) regarding the compliance of cosmetic producers and business operators within the territory of the People’s Republic of China with laws, regulations, mandatory national standards, technical specifications, and technical requirements specified in cosmetic registration or filing documents.

Article 3 Cosmetic inspection work shall adhere to the principles of legality, impartiality, scientific rigor, standardization, and risk management.

Article 4 The National Medical Products Administration (NMPA) is responsible for the national administration of cosmetic inspections. Drug regulatory departments at or above the county level are responsible for the administration of cosmetic inspections within their respective administrative regions.

Article 5 When a drug regulatory department organizes an inspection according to law, the cosmetic producers, business operators, and other inspected units and individuals (hereinafter collectively referred to as the inspected party) shall accept the inspection, cooperate actively, and shall not refuse, evade, or obstruct the inspection.

Article 6 Drug regulatory departments and their established or designated inspection agencies shall carry out inspection work in accordance with laws, regulations, and rules. National-level inspection agencies are responsible for organizing inspections in areas such as cosmetic production assigned by the NMPA and assisting the NMPA in guiding the cosmetic inspection work of drug regulatory departments in provinces, autonomous regions, and municipalities directly under the Central Government.

Inspection agencies shall establish and implement management systems and standard operating procedures for inspection work, continuously improve cosmetic inspections, and ensure inspection quality.

Article 7 Based on the nature and purpose of the inspection, cosmetic inspections are categorized into license-related inspections, routine inspections, for-cause inspections, and other inspections.
(1) License-related inspection refers to an inspection conducted by the drug regulatory department during the cosmetic production licensing process to verify whether the applicant meets the conditions stipulated by laws and regulations.
(2) Routine inspection refers to a planned inspection conducted by the drug regulatory department to verify the inspected party’s compliance with laws, regulations, mandatory national standards, technical specifications, and technical requirements specified in cosmetic registration or filing documents.
(3) For-cause inspection refers to a targeted inspection of the inspected party initiated based on risk information identified from sources such as registration/filing, sampling and testing, adverse reaction monitoring, risk monitoring, complaints and reports, case investigation, and public opinion monitoring.
(4) Other inspections refer to inspections other than license-related, routine, and for-cause inspections.

Article 8 Based on the method of inspection, cosmetic inspections are categorized into on-site inspections and off-site inspections. On-site inspection is the primary method of cosmetic inspection.

On-site inspections may be conducted with prior notification to the inspected party regarding the inspection arrangement, or may be conducted without prior notification.

Off-site inspections include reviewing written materials submitted by the inspected party, conducting remote inspections using digital technology, etc.

Article 9 For cases involving contracted production, the drug regulatory departments of the locations of the cosmetic registrant/filer and the contract manufacturer shall respectively be responsible for inspection work, strengthen the mutual notification of inspection information, and may conduct joint inspections when necessary.

Chapter II: Inspection Procedures and Requirements

Article 10 A drug regulatory department may conduct inspections itself or assign inspection tasks to an inspection agency. When assigning an inspection task, the drug regulatory department shall provide the inspection agency with relevant information about the inspected party and clearly specify inspection requirements.

Article 11 The dispatching inspection unit shall dispatch inspectors with legal knowledge, professional knowledge, and training experience appropriate to the inspection work. The number of inspectors shall not be less than two. When necessary, the dispatching inspection unit may invite experts from relevant fields to participate in the inspection.

Article 12 Upon arrival at the inspection site, inspectors shall present their law enforcement certificates, inspector certificates, or authorization documents issued by the dispatching inspection unit to the inspected party.

Article 13 Inspectors shall conduct on-site inspections according to the requirements of the dispatching inspection unit. If adjustments to important matters such as inspectors, inspection schedule, inspection content, or the inspected party are required, inspectors shall seek approval from the dispatching inspection unit.

As needed for the inspection, inspectors may record the inspection situation truthfully by means such as reviewing and copying materials, video recording, photography, and collecting physical evidence; they may sample the inspected party’s products, materials, etc.

An on-site inspection record shall be generated. The on-site inspection record shall include the name, address, and unified social credit code of the inspected party, the reason and basis for the inspection, inspection content, inspection time, names of inspectors, defects and problems identified, and shall be accompanied by relevant supporting materials when necessary; if risk control measures need to be taken against the inspected party’s products, or if suspected illegal activities are discovered involving the inspected party or if the case requires coordination between inspection and investigation, the on-site inspection record shall also include handling opinions or suggestions for the inspected party. After the inspected party has presented statements or defenses, the relevant on-site inspection record shall be signed by all inspectors and countersigned by the responsible person of the inspected party or sealed with the unit’s official seal; if the responsible person refuses to sign or affix the seal, this shall be noted.

Defects and problems identified during the inspection shall be documented in writing, with one copy held by each party.

Article 14 If the inspected party has objections to the on-site inspection record, they may present statements and defenses on-site. Inspectors shall faithfully record these, verify the content of the statements and defenses, and determine the defects and problems existing with the inspected party based on the combined content.

Article 15 If the dispatching inspection unit is an inspection agency, it shall review the on-site inspection procedures and records; if suspected illegal activities are discovered involving the inspected party or if the case requires coordination between inspection and investigation, it shall issue an inspection review report.

The inspection review report shall include the name, address, and unified social credit code of the inspected party, the reason and basis for the inspection, inspection content, inspection time, names of inspectors, defects and problems identified, handling suggestions for the inspected party, and shall clearly state the inspection review conclusion. The inspection agency shall draw the inspection review conclusion based on cosmetic supervision and administration laws and regulations, the on-site inspection record, and relevant evidentiary materials. The inspection review report shall be signed by the reviewing personnel and the head of the inspection agency, and sealed with the agency’s official seal.

If, upon review, the inspection agency requires further clarification of the content of the on-site inspection record, it shall provide the content requiring clarification to the inspected party in writing for confirmation.

The number of personnel conducting the inspection review shall not be less than two cosmetic inspectors. The inspection review report may serve as a basis for administrative penalties.

Article 16 If an inspection reveals that a cosmetic has caused human injury or there is evidence proving it may endanger human health, inspectors shall immediately report to the dispatching inspection unit and to the drug regulatory department of the location of the inspected party.

The drug regulatory department of the location of the inspected party shall, according to law, take emergency control measures such as ordering the suspension of production or business operations for the involved products; if risk control measures need to be taken nationwide for the product, it shall report step by step to the provincial-level drug regulatory departments of the locations of the cosmetic registrant, filer, or domestic responsible agent indicated on the product label; upon receiving the notification, the provincial-level drug regulatory departments shall issue safety warning information according to law and simultaneously notify other provincial-level drug regulatory departments. Provincial-level drug regulatory departments shall, according to law, conduct risk control work for the involved products within their respective administrative regions.

Article 17 If defects and problems are identified with the inspected party during an inspection, inspectors shall urge them to rectify within a specified timeframe according to law.

The inspected party shall carry out rectification regarding the identified defects and problems within the specified time and submit a rectification report as required. The rectification report shall include the main problems, investigation analysis and risk assessment, risk control measures, and post-rectification effectiveness.

Regarding the rectification situation, the local drug regulatory department of the inspected party may organize an on-site re-inspection if necessary. If the inspected party fails to rectify as required or is suspected of illegal activity, the drug regulatory department shall initiate an investigation according to law.

Article 18 When a higher-level drug regulatory department organizes an inspection, it may, based on inspection needs, request the lower-level drug regulatory department of the location of the inspected party to arrange personnel to assist. The assisting personnel shall comply with the unified arrangements of the inspection work.

Article 19 Inspectors shall strictly comply with laws, regulations, integrity discipline, and work requirements, shall not make demands unrelated to the inspection to the inspected party, and shall have no conflict of interest with the inspected party.

If inspectors fail to perform inspection duties as required and are suspected of illegal activity, they shall be dealt with according to law.

Article 20 Drug regulatory departments, inspection agencies, and their inspectors shall not arbitrarily disclose inspection-related information.

Without the consent of the inspected party, drug regulatory departments, inspection agencies, and their inspectors shall not disclose business secrets of the inspected party learned during the inspection, except as otherwise provided by law or involving national security or significant public interest.

Chapter III: License-related Inspections

Article 21 Cosmetic license-related inspections are categorized into on-site verification for production license application, on-site verification after license renewal, and on-site verification for license changes. The drug regulatory department shall conduct on-site verification of the applicant according to law.

Article 22 For applications for cosmetic production license or license renewal, the drug regulatory department shall conduct on-site verification covering all items in the Cosmetic Production Quality Management Specification Inspection Checklist (Actual Production Version) (hereinafter referred to as the Checklist) within the Inspection Checklists and Judgment Principles for Cosmetic Production Quality Management Specification.

Article 23 For applications for cosmetic production license changes where the drug regulatory department deems on-site verification necessary, it shall conduct on-site verification of relevant items in the Checklist based on the application; if a comprehensive on-site verification is required, the drug regulatory department shall conduct on-site verification covering all items in the Checklist.

Chapter IV: Routine Inspections

Article 24 Drug regulatory departments shall conduct routine inspections of cosmetic producers and business operators based on the principle of risk management.

Article 25 Drug regulatory departments shall adopt a problem-oriented approach and formulate routine inspection plans by comprehensively considering factors such as registration/filing, sampling and testing, adverse reaction monitoring, risk monitoring, complaints and reports, case investigation, and public opinion monitoring, determining the scope of inspected parties, inspection focus, inspection methods, inspection requirements, etc.

Routine inspections shall focus on children’s cosmetics, special cosmetics, cosmetics using new ingredients under monitoring period, as well as cosmetic registrants, filers, and contract manufacturers.

Article 26 For inspections of cosmetic registrants, filers, and contract manufacturers, key items from the Inspection Checklists and Judgment Principles for Cosmetic Production Quality Management Specification shall be the focus of routine inspections.

For inspections of cosmetic business operation activities, drug regulatory departments shall determine the inspection focus based on the purpose of the inspection.

Chapter V: For-cause Inspections

Article 27 Drug regulatory departments may conduct for-cause inspections of cosmetic producers and business operators under any of the following circumstances:
(1) Potential product quality and safety risks are identified during registration/filing, sampling and testing, adverse reaction monitoring, or risk monitoring;
(2) Complaints, reports, or other sources indicate potential product quality and safety risks;
(3) Suspected violations of cosmetic supervision and administration laws and regulations, or suspected non-compliance of products with mandatory national standards, technical specifications, or technical requirements specified in registration/filing documents;
(4) Public opinion monitoring indicates potential product quality and safety risks;
(5) Other circumstances requiring for-cause inspection.

Article 28 For-cause inspections shall focus on whether the inspected party has violated cosmetic supervision and administration laws and regulations, centered around the reason for initiating the inspection.

Article 29 When conducting a for-cause inspection, the dispatching inspection unit shall, in principle, not notify the inspected party in advance of the inspectors or inspection content. Inspectors shall gather at a designated location and proceed directly to the inspection site at the earliest opportunity to inspect for potential problems. Inspectors shall not arbitrarily disclose progress of the inspection, discovered leads of illegal activities, or other such information to the inspected party.

Chapter VI: Coordination between Inspection and Investigation & Cross-Regional Cooperative Investigations

Article 30 During the process of investigating illegal cases, departments responsible for case investigation, cosmetic inspection, etc., shall perform their respective duties, assume their respective responsibilities, and strengthen coordination and linkage.

Article 31 If an inspection discovers suspected illegal activities of the inspected party and the dispatching inspection unit is a drug regulatory department, it shall initiate an investigation according to law; if the dispatching inspection unit is an inspection agency, inspectors shall collect relevant evidence, promptly transfer the leads of illegal activities to the drug regulatory department of the location of the inspected party (hereinafter referred to as the receiving unit), and promptly transfer relevant evidentiary materials such as the on-site inspection record and inspection review report, while sending a copy to the drug regulatory department that assigned the inspection task.

The receiving unit shall promptly organize law enforcement personnel to conduct follow-up investigation and evidence collection.

Article 32 Inspectors may record the inspection and evidence collection process by means such as video recording. Collected evidentiary materials shall be confirmed by signature of relevant personnel of the inspected party or sealed with the unit’s official seal.

Evidentiary materials collected by inspectors during the inspection according to law may serve as a basis for administrative penalties. When necessary, the receiving unit shall verify and confirm the relevant evidence.

Article 33 The receiving unit shall decide whether to file a case according to law and provide written feedback on the filing decision to the dispatching inspection unit within 5 working days from the decision date, stating reasons if not filing; if the dispatching inspection unit is an inspection agency, the receiving unit shall also simultaneously provide feedback to the drug regulatory department that assigned the inspection task.

Article 34 If the receiving unit decides to file a case, it shall provide feedback on the handling result to the dispatching inspection unit within 10 working days from the date of making the decision on whether to impose an administrative penalty on the inspected party; if the dispatching inspection unit is an inspection agency, the receiving unit shall also simultaneously provide feedback to the drug regulatory department that assigned the inspection task.

Article 35 If a drug regulatory department requires assistance from other drug regulatory departments for investigation and evidence collection during case investigation, it may submit a cooperative investigation request across regions to the competent provincial or lower-level drug regulatory department. For cosmetic registration/filing information, cosmetic production license information, business license information, etc., that can be queried through government websites, relevant evidence can be secured by means such as printing, photographing, or video recording; in principle, no cooperative investigation is required. The cooperative investigation request shall be issued in the form of a letter of assistance for investigation, including clear reasons for the request, matters for investigation, contact person and information, and shall be accompanied by materials necessary for the cooperative investigation.

For cross-regional case cooperative investigations, the drug regulatory department may dispatch personnel to the site to jointly conduct investigation and evidence collection with the competent provincial or lower-level drug regulatory department.

Article 36 The drug regulatory department undertaking the cooperative investigation shall complete the work and respond with the investigation results within 15 working days from receiving the letter of assistance for investigation; under urgent circumstances, it shall complete the work and respond within 7 working days or within the period requested; if an extension is needed, it shall inform the requesting drug regulatory department before the deadline.

Article 37 During case investigation, if a drug regulatory department discovers leads of illegal activities involving other competent drug regulatory departments, it shall promptly notify them; such notification does not affect the continuation of the ongoing case investigation. The drug regulatory department receiving the leads shall promptly organize an investigation and provide feedback on the results.

If a drug regulatory department discovers leads of illegal activities during inspection that are not within its duties or jurisdiction, it shall promptly transfer them to the competent department.

Article 38 During case investigation, if a drug regulatory department discovers suspected criminal activity, it shall transfer the case to the public security authority according to law.

Chapter VII: Handling of Inspection Results

Article 39 Based on the inspection results and following the principle of risk management, the drug regulatory department may, according to law, take corresponding measures against the inspected party, such as ordering rectification within a time limit, ordering suspension of production or business operations, ordering recalls, initiating investigation, conducting accountability interviews, or recording in the credit file.

Article 40 After safety risks and hidden dangers are eliminated, the inspected party may apply to the drug regulatory department that made the risk control decision for lifting the measures, and submit a rectification report. The drug regulatory department shall organize an assessment of the rectification situation within 15 working days from receiving the rectification report, lift the relevant risk control measures upon confirming the rectification meets requirements, and may publish relevant information to the public as needed.

Article 41 If the inspected party refuses, evades, or obstructs inspection, or forges, destroys, or conceals evidence, etc., it may be deemed that safety hazards exist during their production and business operations. The drug regulatory department shall, based on the inspection situation, handle the matter according to provisions such as Articles 57 and 74 of the Regulations on the Supervision and Administration of Cosmetics or transfer it to the competent department, and promptly disclose the inspection information.

The following acts by the inspected party shall be deemed as refusal, evasion, or obstruction of inspection:
(1) Refusing, obstructing, or restricting inspectors from entering the inspection site or area, restricting inspection time, or restricting inspectors from leaving at the end of the inspection;
(2) Not providing truthfully or refusing to provide without documents, records, invoices, vouchers, electronic data, and other materials related to the inspection;
(3) Refusing or restricting evidence collection work such as reviewing and copying, video recording and photography, and sampling;
(4) Deceiving, misleading, or evading inspection by claiming staff are absent or by using impersonation;
(5) Other acts of refusing to cooperate with the inspection.

Article 42 Drug regulatory departments shall disclose information about inspections they organize through channels such as their government websites according to law. Disclosure content shall include basic information of the inspected party, inspection basis, inspection results, etc.

Chapter VIII: Supplementary Provisions

Article 43 “Cosmetic producers and business operators” as referred to in these Measures includes cosmetic registrants, filers, contract manufacturers, domestic responsible agents, business operators, organizers of centralized cosmetic trading markets, exhibition organizers, e-commerce platform operators, as well as beauty salons, hotels, etc., that use cosmetics in their business or provide cosmetics to consumers.

Article 44 Inspections related to the registration and filing of cosmetics and new cosmetic ingredients, toothpaste and new toothpaste ingredients shall be conducted with reference to these Measures.

Extension inspections conducted by drug regulatory departments on suppliers and producers of cosmetic raw materials and packaging materials in direct contact with cosmetics based on supervisory needs shall be conducted with reference to these Measures.

Article 45 Inspections of toothpaste production and business operation activities shall be conducted in accordance with these Measures.

Article 46 Provincial-level drug regulatory departments may formulate detailed implementation rules for cosmetic inspection work within their respective administrative regions based on these Measures and local.

Article 47 These Measures shall come into effect on November 1, 2024.