The National Medical Products Administration just issued an announcement on the release of several regulations to support the innovation of cosmetic raw materials.
In order to implement the spirit of the third Plenary Session of the 20th CPC Central Committee, further deepen reform, improve the innovation mechanism of cosmetics, focus on encouraging the innovation of cosmetic raw materials, and aim at building a collaborative innovation system of cosmetic raw materials oriented by market demand, these provisions are formulated and released on 6th of February, 2025 by National Medical Products Administration (NMPA) and came into force on the same day.
Optimize the technical requirements for registration and filing of new raw materials
Improve the classification management and technical evaluation system for new cosmetic ingredients. Based on the characteristics, functions, intended uses, and innovative features of the ingredients, optimize technical requirements and provide enhanced technical guidance for companies in assessing and classifying new ingredients. For new ingredients used domestically or internationally for the first time, refine safety evaluation requirements according to actual risk levels. On the basis of scientifically conducted safety assessments by companies, reduce some toxicological and long-term human trial safety test requirements; for new ingredients with a well-established history of safe use, clarify standards for safety use and consumption history research, enhance the utilization of existing data, and simplify safety evaluation requirements; for new ingredients that are improvements or innovations based on already used ingredients, fully consider their safety usage history and establish corresponding technical requirements. Define the innovative pathways for marketed new ingredients and develop guidelines for innovation studies.
Promote the simultaneous declaration of new raw materials and related products
Strengthen research and development of new ingredients and cosmetics, improve the efficiency of their review and approval processes, and accelerate the market launch of products using new ingredients. For new cosmetic ingredients applying for registration, encourage the simultaneous submission of applications for special cosmetics using these new ingredients; for new cosmetic ingredients registered as special cosmetics, applications for special cosmetic registration can be submitted concurrently with the registration of the new ingredient. Optimize and upgrade the intelligent review system for cosmetics to provide more convenient services for the registration and filing of new ingredients and special cosmetics using new ingredients.
Strengthen the innovation service and application transformation of new raw materials
Support the innovation and application of new raw materials. For those that meet certain conditions and are intended for the first market release in China, using modern science and technology combined with traditional Chinese characteristic plant resources for research and development, early intervention and full-process guidance will be implemented to enhance the quality of new raw material R&D and accelerate their application speed. A dedicated review channel will be set up for applications to register new raw materials that meet these conditions, as well as special cosmetics using these new raw materials, with priority review to expedite the market entry of new raw materials and the relevant special cosmetics.
Strengthen technical guidance and communication of new raw materials
Accelerate the formulation of technical guidelines for new raw material naming and other related research, promptly release technical Q&A on common issues, and strengthen applied research and technical guidance for new technologies and methods. Further optimize and improve the communication and exchange mechanism for new cosmetic ingredients, enhance communication before registration and during review and verification, and guide enterprises to standardize their registration and filing work. Strengthen technical exchanges and coordination between national authority and provincial regulatory authorities, select provincial regulatory authorities with certain conditions and capabilities, and fully leverage their positive role in preliminary consultation, communication, and follow-up guidance.
Improve the safety monitoring period management of new raw materials
Improve the management mechanism for the safety monitoring period of new raw materials, enhance inter-departmental collaboration and cross-regional coordination in filing, evaluation, standards, adverse reaction monitoring, and informatization. Strengthen the monitoring of adverse reactions to cosmetics using new raw materials, expand and improve the adverse reaction monitoring network for cosmetics, enhance the analysis and evaluation of adverse reactions, promptly identify relevant risk signals, and take timely risk control measures for cosmetics that cause harm or have evidence suggesting potential health risks. Research and establish a dynamic adjustment mechanism for the list of already used raw materials.
Strengthen technical guidance on the development of cosmetic raw material standards
According to the technical requirements for defining and classifying cosmetics in China, as well as the needs for cosmetic formulas and production, a technical guide on the purpose of using cosmetic ingredients has been formulated. On the basis of gradually establishing technical requirements for different categories of cosmetic ingredients such as biotechnology and plant resources, research is conducted on general technical requirements for cosmetic ingredients to promote the improvement of cosmetic ingredient standards.
Promote the revision of standards for cosmetic raw materials
Fully leverage the role of the Cosmetics Standardization Technical Committee of National Medical Products Administrations to prioritize the formulation of standards for raw materials with high usage and safety risks in the industry, as well as those that are traditional and advantageous in China. Track the management dynamics of cosmetics raw material standards both domestically and internationally, refer to the monitoring and evaluation of cosmetics safety risks, and draw on the latest safety assessment conclusions from international authoritative institutions to carry out standard conversion. Continuously promote the revision and formulation of cosmetics raw material standards.
Strengthen basic research related to raw materials
Encourage research on the production processes, quality standards, safety assessments, and efficacy evaluations of cosmetic ingredients to enhance their quality. Deepen studies on alternative methods for animal testing and accelerate their application in the safety assessment of new ingredients. Relying on the National Medical Products Administrations platform and key projects for cosmetic regulatory science, promote the application of new technologies, methods, and standards in the innovative development and regulation of cosmetic ingredients.
Strengthen the information construction of cosmetic raw materials
Construct an archive for new cosmetic ingredients and their registrants, enhancing the integration and information sharing between new ingredients and cosmetics data. This will provide data support for the supervision and management of new ingredients and cosmetics using these ingredients. Strengthen research and analysis on the application scenarios of data in the ingredient management process to offer informational guidance and services to the industry.