为了解2005—2020年中药新药临床试验（investigational new drug，IND）申请及审评审批的实际情况，分析中药IND研究及评价的规律，对相关中药新药IND申请情况进行了较系统的整理，从申请品种数量、审批结论情况、注册分类、治疗领域、处方来源、剂型分布、地域分布、开展临床试验情况等方面进行了分析，结果显示：（1）2005—2020年申请IND的中药新药品种总数为1096个。注册分类以6类最多，且批准率较高，而有效部位批准率较低。此外，注射剂的批准率较低。62%的中药新药品种的适应症集中在呼吸、消化、精神神经、妇科、心血管。获得IND批准的588个中药新药制剂中，有319个品种进行了临床试验登记，27个已申请药品上市许可（new drug application，NDA）。（2）从召开临床试验申请前（pre-IND）沟通交流会的品种数、IND申请获批后开展临床试验的情况、2021年申请IND的品种数分析，中药新药研发积极性有明显提高的迹象。（3）临床经验方等具有较好人用经验的中药新药IND批准率较高，而有效部位、科研方的批准率相对较低。

In order to understand the actual situation of investigational new drug (IND), review and approval of new Chinese medicines, and analyze the law of clinical trial research and evaluation of new Chinese medicines, the situation of IND of new Chinese medicines from 2005 to 2020 were systematically carried out in this paper. The number of applications, approval conclusions, registration classification, therapeutic areas, source of prescriptions, dosage form distribution, geographical distribution, and status of clinical trials were analyzed. Results showed that: (1) From 2005 to 2020, the total number of IND applications for new Chinese medicines was 1096. The number of registration classification 6 of new Chinese medicines was the largest with the relatively high approval rate, while registration for effective parts of new Chinese medicines approval rate was low. In addition, the approval rate of injections was low. A total of 62% of the therapeutic areas of new Chinese medicines were focused on breathing, digestion, neuropsychiatry, gynecology and cardiovascular. Among 588 approved traditional Chinese medicine preparations of IND, 319 preparations had recorded on the clinical trial registration platform, and 27 preparations had applied for new drug application (NDA). (2) From the analysis of the number of pre-IND communication meetings, clinical trials of IND approved, and the number of IND in 2021, there were signs of obvious improvement in the enthusiasm of new Chinese medicines research and development. (3) The IND approval rate of new Chinese medicines with human experience, such as clinical experience prescriptions, was relatively high, while the approval rate of effective parts and scientific research prescriptions was relatively low.

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