摘要
Abstract
After three decades of continuous advancement,TCM modernization has achieved notable progress in quality control,clinical evaluation,manufacturing technology,standard development,and industrial growth.At present,the key challenge that TCM modernization facing is no longer primarily how to explain traditional experience with the assistance of modern science,but how to define the basic conditions under which TCM products can be recognized as modern medical products.In response,this paper proposes a four-dimensional criteria framework for TCM modernization:reproducible quality,verifiable efficacy,model-ready data,and auditable processes.These four criteria correspond respectively to the core requirements of the material,clinical,cognitive,and governance foundations of TCM modernization,and together constitute the basic conditions for integrating TCM into the modern medical system.The paper further explicates that this framework not only provides an analytical basis for defining modern TCM but also implies a strategic shift in the underlying logic of TCM research and development,evaluation,regulation,industrial upgrading,and international integration.The next stage of TCM modernization lies not in repeatedly proving that TCM"can be modernized"through additional technologies,but in redefining TCM as a modern medical product through system capabilities that are reproducible,verifiable,model-ready,and auditable.关键词
现代中药/中药现代化/质量一致性/临床证据/数据建模/全过程追溯/监管科学Key words
modern TCM/TCM modernization/quality consistency/clinical evidence/data modeling/full-process traceability/regulatory science
