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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 Suggestions can be submitted via email to [email protected] until November 10.
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 46 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:
1. Inspection of:
Registration and notification of new cosmetic ingredients (NCIs);
Registration and notification of cosmetic products;
Toothpaste notification;
Extension inspections conducted by medical products administration departments on suppliers and manufacturers of cosmetic ingredients and primary packaging materials, as required for regulatory purposes.
2. Inspection of toothpaste production and operation.
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:
| All items specified in Attachment 1 of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices | |
Routine Inspection | The medical products administration departments are responsible for conducting scheduled inspections based on their annual work points to assess the compliance of inspection objects with laws and regulations, mandatory national standards, and technical specifications.
The primary inspection objects include children's cosmetics, special cosmetics, cosmetics added with NCIs during the monitoring period, cosmetic manufacturers, and e-commerce platform operators with significant cosmetics transaction volume. 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 | All or specific key items specified in Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices |
Operation process | Whether a purchase inspection and recording system has been established and implemented | ||
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, 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 laws and regulations, mandatory national standards, and/or technical specifications | |
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.
ChemLinked expects to assist companies in registering/notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at [email protected].
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