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Effective on the issuance date, 26 January 2025, the National Medical Products Administration (NMPA) has started implementing “Several Provisions on Supporting Innovation in Cosmetic Ingredients (No. 12 of 2025)”. There are nine key policy measures aimed at fostering cosmetic ingredient innovation, building a market-oriented collaborative system, and accelerating high-quality industry development. By optimizing regulatory frameworks, enhancing safety assessments, and streamlining approval processes, these provisions aim to facilitate the integration of innovative raw materials into the cosmetic industry while maintaining stringent safety standards.
1. Optimizing Registration and Filing Requirements
The classification and technical evaluation system for new cosmetic ingredients has been refined to align with their characteristics, functions, intended uses, and level of innovation. Key updates include:
Streamlining safety evaluation requirements for new ingredients, especially for those with a history of safe use
Reducing toxicology and long-term human testing requirements for ingredients with scientifically backed safety assessments
Establishing clear pathways for modifications to approved ingredients, ensuring a structured approach to ingredient development
2. Simultaneous Application for New Ingredients and Associated Products
To expedite market entry, regulatory authorities encourage the simultaneous submission of new ingredient applications alongside related cosmetic product registrations. Key measures include:
Allowing special cosmetic products containing new ingredients to be registered concurrently with the ingredient itself
Enhancing the digital evaluation system to provide more efficient processing for new ingredient registrations and their associated products
3. Strengthening Innovation Support and Application Acceleration
Recognizing the importance of groundbreaking research, authorities have introduced special mechanisms to facilitate innovation. These include:
Early-stage involvement and continuous guidance for new ingredients that incorporate advanced scientific techniques or leverage traditional botanical resources
Priority review pathways for new ingredient registrations and the cosmetics formulated with them, ensuring quicker approval and market access
4. Enhancing Technical Guidance and Communication
To improve regulatory transparency, new measures focus on:
Developing technical guidelines for ingredient naming and classification
Addressing common industry concerns through timely technical Q&A sessions
Strengthening communication between national and regional regulatory bodies to support companies in the registration and evaluation processes.
5. Strengthening Safety Monitoring and Risk Management
To maintain high safety standards, the regulatory framework includes:
Improved mechanisms for monitoring the safety of newly introduced ingredients
Expansion of the cosmetic adverse reaction monitoring network to detect and address potential health risks
The establishment of a dynamic system for updating the list of approved ingredients
6. Advancing Research on Ingredient Standards
Regulatory bodies are working to establish clearer standards for cosmetic ingredients, focusing on:
Developing technical guidelines based on ingredient purpose, formulation needs, and manufacturing processes
Setting specific requirements for different categories of ingredients, such as biotechnology-based and plant-derived raw materials
7. Promoting the Standardization of Cosmetic Ingredients
To enhance safety and efficacy, authorities are prioritizing the development of national standards for widely used, high-risk, or unique traditional ingredients. This includes:
Monitoring global regulatory trends and safety assessments
Aligning local standards with international best practices to facilitate global market integration
8. Encouraging Foundational Research on Cosmetic Ingredients
Support for in-depth research on cosmetic ingredient production, safety evaluation, and efficacy testing is being strengthened. Efforts include:
Promoting alternative testing methods to reduce reliance on animal testing
Leveraging national scientific research platforms to drive innovation and regulatory advancements
9. Enhancing Digital Infrastructure for Ingredient Management
The development of a comprehensive database for cosmetic ingredients and their registrants is a major step toward greater transparency and efficiency. Key initiatives include:
Strengthening data integration between new ingredient registrations and cosmetic product approvals
Utilizing big data analytics to provide industry stakeholders with valuable insights and regulatory guidance
Conclusion
These regulatory updates mark a significant step forward in fostering cosmetic ingredient innovation while maintaining rigorous safety standards. By optimizing the approval process, enhancing technical support, and strengthening industry collaboration, these measures will contribute to a more dynamic and globally competitive cosmetic industry.
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