On January 18, 2023, China National Medical Products Administration (NMPA) decided to further optimize the management measures for filing inspection of general cosmetics according to the Cosmetics Supervision and Administration Regulations, Provisions for Registration and Filing of Cosmetics, and other regulations. Relevant matters are hereby announced as follows:
1. As of January 18, general cosmetics that have adopted the inspection method as the quality control measure with a production process that has been included in the daily supervision scope of the provincial drug regulatory department and the product safety risk assessment results can fully confirm the product safety, the filing person can submit the inspection report issued by itself or the entrusted manufacturing enterprise according to the relevant requirements of the cosmetics technical specification when conducting cosmetic notification. Except under one of the following circumstances:
The product is claimed to be used by infants and children;
The product uses new cosmetic ingredients within the safety monitoring period;
The product claims anti-acne, nourishment, repair, anti-wrinkle, anti-dandruff, deodorant, and other cosmetic efficacy;
Other situations where the product may have high safety risks.
If the self-inspection report is submitted during the product filing, the filing person shall also submit a statement of the corresponding inspection ability of the cosmetics filing inspection specified in the Work Specifications for Cosmetics Registration and Record-filing Inspection, provide a description of the corresponding inspection personnel, equipment and facilities, and the site environment for self-inspection, and promise to be responsible for the authenticity and accuracy of the inspection report.
2. If the filing inspection is carried out by self-inspection, the filing person or entrusted manufacturing enterprise shall obtain the cosmetics production license according to law, have the corresponding inspection ability, establish and implement the inspection management system and laboratory management system, and carry out the inspection and issue the inspection report in accordance with the inspection items and relevant inspection requirements specified in the Work Specifications for Cosmetics Registration and Record-filing Inspection. The filing person or the entrusted manufacturing enterprise shall incorporate the self-inspection into the cosmetics quality management system, equip the inspection facilities suitable for the product inspection requirements, have the corresponding quality inspection department or full-time inspection personnel, and strictly control the inspection process. The filing person shall strengthen the management of inspection samples, be responsible for the authenticity of samples, the scientificity, and rationality of inspection items, and ensure the authenticity, accuracy, integrity, and traceability of inspection results.
3. Each provincial drug regulatory department shall strengthen the supervision measures, organize the technical verification of the data after the product filing, strengthen the supervision of the filing person or entrusted manufacturing enterprise that carries out the filing inspection by self-inspection, inspect the establishment and implementation of the enterprise inspection management system and the laboratory management system, and focus on the inspection ability, inspection records, etc. If the filing persons are found to have provided false self-inspection reports and illegal acts, they shall be seriously investigated and dealt with according to law.