[關(guān)鍵詞]
[摘要]
經(jīng)典名方的研發(fā)受到國家戰(zhàn)略支持,是中藥產(chǎn)業(yè)發(fā)展的新機(jī)遇,是傳承中藥弘揚(yáng)經(jīng)典的新舉措。當(dāng)前,雖然對(duì)經(jīng)典名方實(shí)行簡(jiǎn)化注冊(cè)審批政策,但業(yè)界仍對(duì)經(jīng)典名方的研發(fā)存在疑問。梳理出業(yè)界和審評(píng)審批部門現(xiàn)階段共同面臨的6個(gè)共性問題,并對(duì)可能存在的"漲料"問題進(jìn)行分析。提倡發(fā)揚(yáng)跨界合作精神,妥善解決現(xiàn)存的共性問題,加快古代經(jīng)典名方中藥復(fù)方制劑的上市進(jìn)程。
[Key word]
[Abstract]
The research and development of the classical famous prescription is supported by the national strategy, a new opportunity for the development of the traditional Chinese medicine (TCM) industry, and a new measure to carry out the classics of TCM. At present, although the abbreviated registration approval policy has been implemented for the classical famous prescription, the industry still has doubts about the development of the classical famous prescription. This paper sorts out the six common issues faced by the industry and the review and approval departments at this stage, and analyzes the possible "increasing extract" problem. Promote the spirit of cross-border cooperation, properly solve existing common issues, and speed up the listing process of ancient classic TCM compound preparations.
[中圖分類號(hào)]
[基金項(xiàng)目]