通過對(duì)中藥上市后安全監(jiān)管的研究，為科學(xué)挖掘中藥醫(yī)學(xué)價(jià)值、降低使用風(fēng)險(xiǎn)提供監(jiān)管支持。以短語檢索法查閱并研究分析國家監(jiān)管部門發(fā)布實(shí)施的中藥監(jiān)管相關(guān)規(guī)范性文件和公示信息，對(duì)中藥上市后安全監(jiān)管現(xiàn)狀進(jìn)行歸納總結(jié)，為立足監(jiān)管關(guān)注中藥上市后安全提出見解。2013—2023年我國制定的《中藥注冊(cè)管理專門規(guī)定》等8部規(guī)范性文件中涵蓋中藥上市后安全監(jiān)管相關(guān)內(nèi)容，但未結(jié)合其特性建立專屬性高的中藥上市后安全監(jiān)管制度體系；近10年的中藥說明書安全性信息修訂公告均由國家藥品監(jiān)督管理局發(fā)布；中藥不良反應(yīng)報(bào)告占比為13%，企業(yè)自主報(bào)告力度不夠；古代經(jīng)典名方中藥復(fù)方制劑的安全性信息需持續(xù)完善。應(yīng)認(rèn)識(shí)到關(guān)注中藥上市后安全的現(xiàn)實(shí)意義，從構(gòu)建制度體系、建立聯(lián)動(dòng)機(jī)制、體現(xiàn)中藥特性和強(qiáng)化責(zé)任落實(shí)等方面推動(dòng)中藥上市后安全監(jiān)管。

Through the research on the post-marketing safety regulation of traditional Chinese medicine, it can provide regulatory support for scientifically mining the medical value of traditional Chinese medicine and reducing the use risk. The phrase search method was used to consult and analyze the relevant normative documents and public information of traditional Chinese medicine supervision issued and implemented by the national regulatory authorities, and the current situation of the safety supervision of traditional Chinese medicine after marketing was summarized, so as to provide insights for focusing on the safety of traditional Chinese medicine after marketing based on supervision. From 2013 to 2023, eight normative documents, including the Special Regulations on the Registration and Management of Chinese Medicine, have covered the relevant contents of post-listing safety supervision of Chinese medicine, but a highly specialized post-listing safety supervision system of Chinese medicine has not been established according to its characteristics. In the past ten years, the announcement of the revision of the safety information of traditional Chinese medicine instructions was issued by the State Drug Administration, the proportion of adverse reactions reported by traditional Chinese medicine is about 13%, and the independent reporting of enterprises is insufficient, the safety information of classical Chinese medicine compound preparations needs to be continuously improved. We should realize the practical significance of paying attention to the post-marketing safety of traditional Chinese medicine, and promote the post-marketing safety supervision of traditional Chinese medicine from the aspects of building a system, establishing a linkage mechanism, reflecting the characteristics of traditional Chinese medicine, and strengthening the implementation of responsibility.

R95

南京市市場(chǎng)監(jiān)督管理局2022年度重點(diǎn)科技項(xiàng)目(Kj2022049)