The research and development of new traditional Chinese medicine(TCM) drugs has entered a phase integrating high-quality development with resource assurance. Drawing from 18 new TCM drug registration resource assessment projects, this study systematically summarizes three core challenges in TCM resource management:(1) industrial chain complexity amplifies quantity-quality risks through material heterogeneity(multi-origin variations and wild-to-cultivated genetic shifts) and production chain coupling(germplasm-cultivation-processing whole-chain volatility);(2) structural misalignment among institutions, enterprises, and producers leads to disattachment of research and development from industrial demand;(3) technical barriers exist in quality control systems, involving producing area shift, cultivation evolution, and harvesting and processing innovations. This study proposes a four-dimensional assessment framework prioritizing "species stabilization, quantity availability, quality control, and quality optimization", which is supported by an early-warning system addressing multi-origin selection, adulterant control, endangered species protection, and standardized cultivation. Risk management strategies emphasize supply chain traceability, particularly for imported and ethnic medicinal materials. Using Epimedii Folium as a case study, this study demonstrates a tripartite industrial upgrade paradigm integrating premium germplasm, cultivation technology, and quality control, ultimately establishing an innovation mechanism with deep academia-industry collaboration. The research advocates transforming resource assessment from compliance checks to strategic decision-making tools through enhanced academia-industry collaboration, so as to provide resource assurance for high-quality TCM development.
Guo et al. (Tue,) studied this question.
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