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Editor's note: This article was originally published on April 30, 2024, and was updated on November 1, 2024, as per the latest developments. The updated contents are marked in red below.
On October 19, 2023, China National Medical Products Administration (NMPA) solicited opinions on Administrative Measures on Cosmetics Inspection (hereinafter referred to as the "Measures"). 1 On April 29, 2024, NMPA released the finalized Measures and implemented it on November 1, 2024. 2
The Measures represents the first system construction by NMPA aimed at comprehensively standardizing cosmetics inspections since the implementation of the Cosmetic Supervision and Administration Regulation (CSAR). With 8 chapters and 47 articles, the Measures systematically clarifies the requirements for inspection categories, inspection procedures, link between inspection and audit, and result handling. It aims to address the main problems currently faced in cosmetics inspection work.
Applicable Scope
The Measures applies to the following areas:
Inspection of:
Registration and notification of cosmetic products and new cosmetic ingredients (NCIs);
Notification of toothpaste and new toothpaste ingredients;
Extension inspections conducted by medical products administration departments on suppliers and manufacturers of cosmetic ingredients and primary packaging materials, as required for regulatory purposes;
Production and operation of toothpaste.
Clarifying Inspection Categories and Inspection Requirements
Cosmetics inspections are categorized into four types as below, based on their nature and purpose.
1. Licensing inspection
2. Routine inspection
3. Cause-based inspection
4. Other inspections
Each type of inspection has specific requirements for the inspection’s initiation, focus, and methods.
Inspection Categories and Focus
Inspection Categories | Introduction | Inspection Focus | |
Licensing Inspection | During the cosmetics production licensing process, the medical products administration department conducts inspections to assess whether the applicant meets the conditions outlined in laws and regulations. The inspection is divided into:
|
| |
Routine Inspection | The medical products administration departments are responsible for conducting scheduled inspections to assess the compliance of inspection objects with laws and regulations, mandatory national standards, technical specifications, and technical requirements specified in registration/notification documents.
The primary inspection objects include children's cosmetics, special cosmetics, cosmetics added with NCIs during the monitoring period, cosmetic registrant, notifier and entrusted production enterprise. Various factors are taken into account during the selection of inspection objects, such as cosmetics registration and notification, sampling inspection, adverse reaction monitoring, risk monitoring, complaint reporting, case investigation and handling, and public opinion monitoring. | Cosmetics registrant, notifier, and entrusted production enterprise | Key items specified in Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices |
Operation process | The items to be inspected should be determined based on the inspection purpose. | ||
Cause-based Inspection | Targeted inspections are conducted on inspected objects based on risk information obtained from registration and notification, sampling inspection, adverse reaction monitoring, risk monitoring, complaints and reports, case investigation and public opinion monitoring.
The medical products administration department may conduct cause-based inspections of cosmetics manufacturers and operators under the following circumstances:
| Whether there are any violations of cosmetic laws and regulations. | |
Inspection Results
Upon reviewing the inspection results and following the risk management principles, the medical products administration department may implement appropriate measures, such as imposing a deadline for rectification, ordering the suspension of production and operations, ordering product recalls, conducting legislative investigations, conducting responsibility interviews, and recording the situation in credit files.
Further Reading
China Implements Supervision and Administration Measures on Cosmetics Manufacture and Operation
China Finalizes Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices
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