2018年11月6日，國(guó)家藥監(jiān)局發(fā)布《證候類中藥新藥臨床研究技術(shù)指導(dǎo)原則》，闡明了證候類中藥新藥的處方來源、基本要求、臨床定位、證候診斷、基本研究思路及試驗(yàn)設(shè)計(jì)、有效性及安全性評(píng)價(jià)、試驗(yàn)質(zhì)量控制與數(shù)據(jù)管理、說明書撰寫原則等。以《證候類中藥新藥臨床研究技術(shù)指導(dǎo)原則》為主線，通過梳理相關(guān)政策法規(guī)，探討"證候類中藥新藥"開發(fā)的機(jī)遇和可能遇到的困難，為"中醫(yī)臨床驗(yàn)方"及不在《古代經(jīng)典名方目錄》中的"傳統(tǒng)經(jīng)方"按照"證候類中藥新藥"開發(fā)提供實(shí)施路徑參考。

The State Food and Drug Administration issued the"Guiding Principles for Clinical Research of New Drugs for Syndromes of Traditional Chinese Medicine"On November 6,2018,which clarified the prescription source,basic requirements,clinical orientation,syndrome diagnosis,basic research ideas of new Chinese medicines for syndromes.Test design,effectiveness and safety evaluation,test quality control and data management,manual writing principles,etc.This article takes the"Guidelines for Clinical Research of New Drugs for Syndrome Chinese Medicine"as the main line,combined with relevant policies and regulations to explore the opportunities and possible difficulties in the development of "New Drugs for Syndrome Chinese Medicine" ,which is the implementation path reference for "Chinese medicine clinical prescription" and the"traditional prescriptions "not in the Ancient Classics Catalogue in accordance with the development of the" New Drugs for Syndrome Chinese Medicine".

山東省科技支撐項(xiàng)目“中醫(yī)經(jīng)典名方的二次開發(fā)”（項(xiàng)目編號(hào)2016CYJS08A01-9）；天津市科技支撐計(jì)劃項(xiàng)目“治療2型糖尿病中藥復(fù)方新藥千金連黃片的臨床前研究”（項(xiàng)目編號(hào)16YFZCSY00620）；天津市科技支撐計(jì)劃項(xiàng)目“治療小兒急性咽喉炎中醫(yī)經(jīng)方新藥小兒升麻合劑的臨床前研究”（項(xiàng)目編號(hào)17YFZCSY00750）