On January 18, 2023, China NMPA (National Medical Products Administration) issued an announcement on matters related to further optimizing the management measures for filing inspection of general cosmetics (No.13, 2023, hereinafter referred to as the Announcement). On March 30, 2023, NMPA issued FAQs on Cosmetics Supervision and Management (6) which focused on Q&A related to the implementation of the Announcement.
1. Why the management measures for filing inspection of general cosmetics should be optimized?
The announcement stipulates that the management measures for filing inspection of some general cosmetics could be optimized on the basis of ensuring product quality and safety. The filing inspection which was originally completed by a third-party qualification inspection institute was adjusted to allow the filer or entrusted manufacturing enterprise to conduct self-inspection of all or part of the items based on their own inspection capabilities. The qualified inspection reports could be submitted as the product filing materials by the filer. This optimization measure aims to encourage enterprises to increase investment in research and development, improve inspection capabilities, and effectively ensure the quality and safety of their products.
2. What conditions should the filer or the entrusted production enterprise meet when conducting the filing inspection through self-inspection?
The Announcement stipulates that in the case of conducting the filing inspection through self-inspection, the filer or entrusted production enterprise should obtain a cosmetics production license according to law, have corresponding inspection capabilities, be equipped with inspection personnel, equipment, and facilities that match the requirements of the inspection items, implement sample management procedures as required. In addition, the filer or entrusted production enterprise incorporates self-inspection into the cosmetics quality management system, establish and implement the inspection management system and laboratory management system, strictly control the inspection process, and issue inspection reports for corresponding inspection items based on the self-inspection results.
3. How should qualified filers or entrusted production enterprises conduct the filing inspection through self-inspection?
In order to standardize the filing inspection management and ensure the accuracy of the self-inspection results, the principle of "who produces, who conducts self-inspection" should be followed. If the product is self-produced, the filer should conduct self-inspection and issue an inspection report. If the product is produced by the entrusted production enterprise, the actual entrusted production enterprise should conduct self-inspection and issue an inspection report.
If the filing inspection items conducted by the filer or entrusted production enterprise through self-inspection fail to cover all the filing inspection items specified in the regulations, the filer or entrusted production enterprise can conduct self-inspection and issue inspection reports for the items they can complete. For other inspection items that are temporarily unable to be conducted, a qualified inspection institute can be entrusted to complete the inspection and issue an inspection report in accordance with the Work Specifications for Cosmetics Registration and Record-filing Inspection. The inspection samples should meet the requirements for filing inspection and be in the same batch as the self-inspection samples.
4. How should the filer or entrusted production enterprise issue a statement of inspection capability when conducting a filing inspection through self-inspection?
According to the Announcement, when conducting the filing inspection through self-inspection, a statement of inspection capability of the cosmetics filing inspection specified in the Work Specifications for Cosmetics Registration and Record-filing Inspection should be submitted at the same time. The filer or entrusted production enterprise that conducts self-inspection should comply with the relevant requirements of cosmetics production and inspection management. The inspection capability of self-inspection should be inspected item by item. For qualified self-inspection items, a statement describing that the filer or entrusted production enterprise has the inspection capability can be provided in the form of an attached page in the self-inspection report. The statement should provide an overview of the inspection capability in terms of inspection personnel, equipment and facility, and site environment based on the actual situation of the self-inspection, and make a commitment to the authenticity and accuracy of the inspection results.
5. What are the requirements for the format and content of product inspection reports issued through self-inspection?
For the filing inspection conducted through self-inspection, the filer or entrusted production enterprise should conduct the inspection work in accordance with the Technical Specification for the Safety of Cosmetics and other relevant technical requirements. The content of the inspection report should be complete, and the inspection results should be accurate and traceable. The format of the inspection report can refer to the inspection report format provided in the Work Specifications for Cosmetics Registration and Record-filing Inspection. The report content should at least include the report number. (which can be determined based on the actual inspection management work in the production process), sample name, quantity and specification of samples and retention samples, production date or batch number, color and form, shelf life of expiration date, completion date of inspection, inspection items (specific item names for microbiological and heavy metal testing), inspection basis (current effective technical specifications and chapter numbers, method number, etc.), inspection results, inspection conclusions, etc. The inspection report should be issued and sealed for confirmation by the filer or entrusted production enterprise that conducts the self-inspection work.
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