通過系統(tǒng)梳理相關(guān)政策法規(guī)、指導(dǎo)原則和研究文獻(xiàn)，結(jié)合筆者的中藥研發(fā)實(shí)踐，在中醫(yī)藥理論、人用經(jīng)驗(yàn)、臨床試驗(yàn)"三結(jié)合"中藥注冊審批證據(jù)體系模式下，重點(diǎn)思考了人用經(jīng)驗(yàn)及其證據(jù)形成、人用經(jīng)驗(yàn)證據(jù)支持兒童中藥新藥注冊和說明書變更幾方面問題，提出了一些個(gè)人認(rèn)識(shí)，供兒童中藥研發(fā)相關(guān)各方參考，以期充分利用人用經(jīng)驗(yàn)證據(jù)，節(jié)約臨床試驗(yàn)資源，加速兒童中藥品種的研發(fā)進(jìn)程。

In this paper, through systematically reviewing relevant policies and regulations, guidelines and research literature, and combining with the author's practice of the research and development of traditional Chinese medicine (TCM), we focus on human experience and its evidence formation, and human experience evidence to support the registration of registration and modification of specification for children's new drug application of traditional Chinese medicine under the "triple combination" TCM registration and approval evidence system model of TCM theory, human experience and clinical trials. In this paper, we have put forward some personal views for the reference of all parties involved in the development of Chinese medicine for children, so as to make full use of human experience and evidence, save clinical trial resources, and accelerate the development of children's Chinese medicine varieties.

R287.5

“十三五”國家科技重大專項(xiàng)——重大新藥創(chuàng)制項(xiàng)目（2020ZX09201-008）