China’s National Medical Products Administration issued the 14th Five-Year Plan on Drug Regulatory Network Security and Information Technology Construction requiring the strengthening of cosmetics regulatory capacity. It also required to build and improve systems and functions such as cosmetics and new cosmetic raw materials registration, filing, cosmetic quality and safety sampling, registration and filing inspection, adverse reaction monitoring, on-site inspection, unannounced inspection and standards revision and others.
On May 11, Beijing time, China’s National Medical Products Administration issued the 14th Five-Year Plan on Drug Regulatory Network Security and Information Technology Construction (hereinafter referred to as the Plan). The Plan proposes to strengthen the regulatory capacity of drugs and cosmetics, and promote the digital and intelligent transformation and upgrading of the drug industry.
The Plan mainly mentions the need to strengthen the integration of cosmetic regulatory business information technology applications and mobile construction including the comprehensive promotion of supervision and inspection, traceability supervision, inspection and testing and other business areas of electronic management. It is contributed to promoting the supervision of the entire process of standardization, digitalization, networking and other aspects of the construction of an intelligent regulatory platform.
The key tasks of the Plan contain the following five aspects: upgrading intelligent regulatory of “two products and one device”, improving the ability to integrate government services, promoting the integration of regulatory data and drive, building a firm digital base of drug intelligent supervision, and strengthening the comprehensive security capacity of network security. Among them, upgrading the intelligent regulatory of “two products and one device” should strengthen the cosmetic regulatory capacity and risk management construction and promote the application system mobile construction.
First of all, in the perspective of strengthening the regulatory capacity of cosmetics, the Plan requires to continue to improve the construction of cosmetics and new cosmetic raw material registration, filing, cosmetic quality and safety sampling, registration and filing inspection, adverse reaction monitoring, on-site verification, unannounced Inspection and standards revision management and other business systems and functions. The cosmetic mobile office and regulatory services should be enhanced to promote the issuance of electronic certificates of cosmetic registration.
Also convergence of cosmetic regulatory data, sharing and application should be strengthened. Research and construction should be implemented in the field of quantitative grading of cosmetic enterprises, variety files, risk analysis and early warning, network monitoring and others to enhance the digital and intelligent level of cosmetic regulation.
Second, in the perspective of strengthening risk management capacity, the Plan requires to promotion the construction of China’s cosmetic adverse reaction monitoring information system for improving the report collection of monitoring information system, information retrieval, statistical analysis and other functions. It aims to the establishment of reporting, easy-to-use and compatible with China’s adverse drug reaction monitoring system.
Finally, in the perspective of promoting the application system mobile construction. The Plan requires continuing to promote “cosmetic supervision” and other key mobile applications. It encourages Chinese drug regulatory departments at all levels to innovate service content, and enhance the breadth of services according to the actual application scenarios for gradually building a new pattern of comprehensive, multi-dimensional drug regulatory mobile Internet services.
In addition, the Plan also requires strengthening analysis and exploring big data for cosmetics supervision and improving the ability of regulatory data resource management and application. And with reference to the construction model of drug variety files, the Plan asks to promote the construction of cosmetic variety files in accordance with the law to strengthen the product variety “one file for one product”. It is contributed to achieving the full life cycle of product management. The construction of a cosmetic safety credit file is required to be promoted to strengthen the “one file for one enterprise”. It aims to achieve the whole process and the whole process management from the laboratory to the end user.
Finally, the National Medical Products Administration asks for strengthening the supervision of cosmetic information standards. It encourages provincial medical products regulatory departments, industry associations, enterprises, scientific research institutions and others to participate in the standard formulation and revision. Cosmetic supervision of key areas of information technology standards and regulations for the development and revision of the work should be carried out including information technology standards and regulations such as electronic certificates, drug traceability, variety files, credit files, administrative licensing and others.