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The National Medical Products Administration of China (NMPA) published the Invite for Response to the Interim Management Regulation on Foreign Cosmetic Facility Inspection (公开征求《化妆品境外检查暂行管理规定(征求意见稿)》意见) (the proposal) on 11 November 2019. Once adopted, the proposal would authorize Chinese authorities to conduct facility inspections of cosmetic manufacturers, including research and development facilities located outside of China, provided that the cosmetic products that they design or manufacture have been sold on the Chinese market or are intended to be marketed in China. Public comments on the proposal will be taken until 22 December 2019.
Verisk 3E Review
Specifically the proposal would authorize the National Medical Products Administration of China (NMPA), along with the Center for Food and Drug Inspection under the NMPA (the center), to conduct inspections of research and development facilities and manufacturing facilities of cosmetic products that are located outside of China if these products have been sold on the Chinese market or are intended to be marketed in China.
In addition the proposal would outline the workflow and timelines for the authorities to conduct this inspection of foreign facilities, as follows:
- Formulation of an annual inspection plan, which would be conducted by the NMPA on the basis of potential safety risks associated with a cosmetic product. This risk may be determined by various factors, such as suggestions from other government agencies, information obtained during product registration and notification, as well as monitoring processes of adverse effects in relation to a cosmetic product
- Initial inspection notification: Once the annual inspection plan is finalized, the center would issue inspection notices to the identified cosmetic companies (concerned companies) under the annual plan, including companies that hold a registration or notification of cosmetic products, as well as their representatives. The concerned company would need to submit the required product information and documentation, as prescribed under Annexes Three and Four of the proposal, to the center within 15-30 days of receiving the notice, depending on the specific information requested
- Final inspection notification: A final inspection notice would be issued by the center once the required product information is submitted by the concerned companies. This notice would contain information on the specific dates and times that the inspections would be carried out. Recipient companies may file a written response within 10 days of receiving this notice to postpone the inspection process, explaining the reasons for this request. Detailed information on this notice can be found under Annex Five of the proposal
- Facility inspection: The inspection would typically be conducted by three to five officers who must not have any possible conflict of interest in the entire inspection process. The principal inspector would start the inspection by announcing the details concerning the upcoming inspection, including the names of inspectors, inspection goals, the scope of the inspection, the legal basis for the inspection, the agenda, as well as other matters. Companies should note that the inspectors would be authorized to collect evidence through photocopy, photography, or videotape. Inspectors would also be able to collect product samples for further analysis
- Inspection results issuance: The inspectors would be required to finalize the inspection results within 10 business days of returning to China. The NMPA would communicate the inspection report containing these results to the concerned companies within 20 business days upon receiving the results from the center. Concerned companies, including their representative, would have up to 10 business days to dispute the results
- Correction phase: This would require corrective measures from concerned companies if the inspection results indicate non-compliance
- Final decision: The center would evaluate both the inspection results and corrective measures taken, if any, to issue a final decision on whether the product inspected is in compliance with applicable Chinese legislation. Various administrative measures may be imposed on the basis of this decision. For instance, the NMPA may suspend the sale of or order the mandatory product recall of a particular cosmetic product that fails the inspection.
Companies should note that the inspection would be conducted in Chinese. All information submitted by the foreign facilities would need to be in Chinese. Translator(s) may be required, if necessary.
Verisk 3E Analysis
Companies that operate in the cosmetics industry should note that China recently proposed the establishment of a foreign cosmetic facility inspection program. This program provides the NMPA with authority to conduct inspections of R&D and manufacturing facilities of cosmetics that are located outside of China, to ensure product safety and regulatory compliance of cosmetic products sold on the Chinese market or intended to be marketed in China. It is recommended that affected parties review the proposal and submit any comments they might have to the NMPA by 22 December 2019 at email@example.com.