Objective: Under the policy background of the reform of the traditional Chinese medicine (TCM) review and approval system, the implementation measures of the review evidence system combining TCM theory, human use experience and clinical trials (referred to as the "three combinations") are explored centering on medical institutions, to provide references for the research and development (R&D) of TCM preparations and new drugs in medical institutions. Methods: According to the relevant requirements of the R&D of TCM new drugs under the "three combinations" review evidence system, the construction of supporting facilities related to human use experience research at the level of medical institutions was strengthened, the service platform of R&D of TCM and achievement transformation was built at the management level, and human use experience research at the clinical level was standardized, to build a R&D and management system for TCM new drugs in medical institutions. Results: The construction of R&D of TCM new drugs and management system in medical institutions is helpful to transform clinical diagnosis and treatment data into empirical evidence supporting the registration of TCM new drug, and promote the transformation of TCM new drug by improving the level of R&D of TCM new drug. Conclusion: The establishment of R&D of TCM new drugs and management system based on "three combinations" in medical institutions is one of the ways to land the evidence system of "three combinations" review and guide the research and development practice.
Lu Yao, Shen Lin, Lu Yuqiao, Liu Dianna, Wang Le, Chen Xu
. The System Construction of Research and Development and Management of TCM New Drug in Medical Institutions Based on the “Three Combination” Review Evidence[J]. Chinese Pharmaceutical Affairs, 2024
, 38(2)
: 147
-151
.
DOI: 10.16153/j.1002-7777.2024.02.004
[1] 新华社.中共中央国务院关于促进中医药传承创新发展的意见[EB/OL].（2019-10-26）[2023-08-29].https://www.gov.cn/gongbao/content/2019/content_5449644.htm.
[2] 国家药品监督管理局.国家药监局关于促进中药传承创新发展的实施意见[EB/OL].（2020-12-25）[2023-08-29].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20201225163906151.html.
[3] 国家药品监督管理局.《中药注册管理专门规定》 政策解读 [EB/OL].（2023-02-10）[2023-08-29].https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/zhcjd/zhcjdyp/20230210173935194.html.
[4] 国家药品监督管理局.中药注册管理专门规定[EB/OL].（2023-02-10）[2023-08-29].https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20230210173401120.html.
[5] 路遥，王海南.浅析“三结合”审评证据体系对中药新药转化的作用[J].生物医学转化，2022，3（3）：12-14，30.
[6] 国家药品监督管理局药品审评中心.基于“三结合”注册审评证据体系下的沟通交流指导原则（试行）[EB/OL].（2022-04-29）[2023-08-29].https://www.cde.org.cn/main/news/viewInfoCommon/8a1682a8d37494732f7f44 1dd11f5af6.
[7] 国家药品监督管理局药品审评中心.基于人用经验的中药复方制剂新药临床研发指导原则（试行）[EB/OL].（2022-04-29）[2023-8-29].https://www.cde.org.cn/main/news/viewInfoCommon/8a1682a8d37494732f7f441dd 11f5af6.
[8] 路遥，申琳，鲁雨荍，等.医疗机构制剂向中药创新药转化过程中临床关键问题思考[J].中国实验方剂学杂志，2023，29（6）：231-236.
[9] 曾宪涛，朱风雷，任学群，等.基于临床科研一体化技术的临床研究[J].中国循证心血管医学杂志，2017，9（10）：1156-1161.
[10] 北京市人民政府.北京市人民政府关于进一步促进科技成果转化和产业化的指导意见[EB/OL].（2011-04-26）[2023-08-29].http://kw.beijing.gov.cn/art/2011/3/15/art_2962_16140.html.
[11] 林志健，王海南.“三结合”注册审评审批证据体系下临床中药师在新药研发中的机遇与挑战[J].中国新药杂志，2022，31（9）：832-835.
[12] 刘敏，田佳懿，年宏蕾，等.某医疗机构中药制剂质量标准存在的问题及修正对策[J].中国药事，2021，35（9）：1060-1065.
[13] 王海南，于江泳，蔡毅，等.刍议对“三结合”中人用经验的认识与思考[C]//2022国家中药科学监管大会论文集[C].北京，2022：46-49.
[14] 朱雪琦，程金莲，李博，等.中药医疗机构在人用经验规范收集整理方面的探索实践与展望[J].中国新药杂志，2022，31（16）：1571-1573.
[15] 杨梅，赵翡翠.基于数据挖掘的含附子中成药组方规律分析[J].中国药事，2022，36（2）：217-224.
