Announcement on Matters Concerning Optimizing the Management Measures for Filing and Inspection of General Cosmetics (No. 13, 2023)

In order to further deepen the reform of “decentralization, management and service” and implement the main responsibility of the enterprise, according to the “Cosmetics Supervision and Administration Regulations”, and in accordance with the principle of risk management, the NMPA (National Medical Product Administration) has decided to further optimize the management of general cosmetics filing and inspection measure.

The relevant matters are hereby announced as follows:

From the date of release of this announcement, When filing or registering a product, the filer can submit the inspection report issued by the cosmetics filer or the entrusted manufacturer to carry out self-inspection in accordance with the relevant requirements of the cosmetics technical specification if the inspection methods are adopted as quality control measures for general cosmetics and the production link has been included in the daily supervision and management scope of the provincial drug supervision and management department, the product safety risk assessment results can fully confirm the product safety.

(Takeaway: domestic-made cosmetics are not needed to do extra testing and can submit the self-inspection report instead).

Except for one of the following situations: 

(1) The product claims to be used by infants and children; 

(2) The product uses new cosmetic raw materials that are still under safety monitoring; 

(3) The product claims to have anti-acne, nourishing, repairing, Anti-wrinkle, anti-dandruff, deodorant and other effects; 

(4) Other situations where the product may have relatively high safety risks. 

If a self-inspection report is submitted during product filing, the filing person shall at the same time, submit a statement of the corresponding inspection capabilities for cosmetics filing inspections stipulated in the “Cosmetics Registration and Filing Inspection Work Specifications”, provide a description of the corresponding inspectors, equipment, facilities, and site environment that carry out the 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 means of self-inspection,the filing party or entrusted production enterprise shall obtain a cosmetics production license according to law, should have corresponding inspection capabilities, establish and implement inspection management systems and laboratory management systems, and carry out inspections and issue inspection reports in accordance with the inspection items and relevant inspection requirements stipulated in the “Cosmetics Registration and Filing Inspection Work Specifications”. The filing party or entrusted production enterprise shall include self-inspection work into the cosmetics quality management system, equip inspection equipment and facilities that meet product inspection requirements, have corresponding quality inspection departments or full-time inspection personnel, and strictly control the inspection process. The filer should strengthen the management of inspection samples, be responsible for the authenticity of the samples, the scientificity and rationality of the inspection items, and ensure that the inspection results are true, accurate, complete and traceable. 
3. Provincial drug regulatory departments should strengthen interim and ex-post supervision measures, organize technical inspection of data after product filing, strengthen supervision and inspection of filing parties or entrusted production enterprises that carry out filing inspections by self-inspection, and inspect enterprise inspections. The establishment and implementation of the management system and laboratory management system, focusing on inspection of its inspection capabilities, inspection records, etc. If the filing party is found to have provided false self-inspection reports and other violations of laws and regulations, it will be severely investigated and punished according to law.  Special announcement.

                                 NMPA

January 13, 2023

Original Source