中药人用经验的现状及伦理审查辨析要点

Current Situation of Human Experience of Traditional Chinese Medicine and the Key Point of Ethical Review

为加快中国中药新药审评审批速度,当前正加速构建中医药理论、人用经验和临床试验相结合的中药注册审评证据体系,优化基于古代经典名方、名老中医方、医疗机构制剂等具有人用经验的中药新药审评审批技术要求。美国对植物药上市申请要求严格,欧盟根据草药药品特点,结合其人用经验,分类注册管理,体现传承与创新的监管理念。中国中药人用经验历史悠久,其应用有适用范围、基本要求,需依据证据分级评价标准以分类减免申报资料。伦理委员会审查中药人用经验研究项目时应关注的审查要点有中药新药或方剂的科学依据、临床定位、适用人群、有效性和安全性信息、研究设计、样本量、利益冲突管理和知情同意等。人用经验有助于制定中药新药研究方案,不仅提升研发成功率,而且降低研发成本,加快中药新药上市,可惠及更多患者。

In order to speed up the review and approval of new drugs of Traditional Chinese Medicine(TCM)in China,it is accelerating the construction of TCM registration review evidence system,which combines the theory of TCM,human experience and clinical trials,and optimizing the technical requirements for the review of and approval of new drugs of TCM based on ancient classic prescriptions,famous old Chinese medicine prescriptions,and medical institution preparations.The United States has strict requirements on the application for the marketing of herbal medicines.According to the characteristics of herbal medicines and combined with human experience,the European Union has classified registration management,reflecting the regulatory concept of inheritance and innovation.TCM has a long history of human use experience in China,its application has a scope of application,basic requirements,and it is necessary to classify and exempt the declaration materials according to the evidence grading evaluation standards.When the ethics committee reviews the research scheme of human experience of TCM,it should pay attention to the review points such as scientific basis for new drugs or prescriptions of TCM,clinical positioning,applicable population,effectiveness and safety information,research design,sample size,conflict of interest management and informed consent.Finally,Human experience is helpful to formulate the research scheme of new drugs of TCM,which can not only improve the success rate of research and development,but also reduces the cost of research and development,accelerate the marketing of new drugs of TCM,and can benefit more patients.