真实世界证据支持医疗机构中药制剂转化为新药的思考

Considerations on the support of converting traditional Chinese medicine preparations of medical institutions into new traditional Chinese medicine using real world evidence

真实世界研究契合中医药复杂干预及个体化诊疗的临床特点,国家积极探索发挥真实世界证据支持中药监管决策的作用,发挥医疗机构中药制剂作为中药新药研发的“孵化器”作用,鼓励医疗机构中药制剂向中药新药转化。本文介绍了真实世界研究国内外政策法规要求,就真实世界证据支持医疗机构中药制剂转化为中药新药的可行性进行了探讨,提出思考与建议。

Real world research/study corresponds to clinical characteristics of complex interventions and individualized treatment by Traditional Chinese Medicine(TCM). The state actively explores the role of real-world evidence in supporting TCM regulatory decision-making, gives full play to the role of TCM preparations as “incubator”, and encourages the conversion of TCM preparations of medical institutions into new TCM. This paper introduces policies and regulations for real-world research, discusses the feasibility of real-world evidence to support the transformation of TCM preparations of medical institutions into new TCM, and puts forward the thinking and suggestions.