中藥上市后變更是已上市中藥持續(xù)管理的重要環(huán)節(jié)，直接關(guān)系到中藥的安全性、有效性、質(zhì)量可控性，但以往中藥上市后變更存在管理路徑不清晰、研究驗(yàn)證欠缺等問題，不利于提升已上市中藥的質(zhì)量。對福建省近10年中藥上市后變更研究資料進(jìn)行回顧性分析，結(jié)合溝通交流案例、審評檢查經(jīng)驗(yàn)，梳理出中藥上市后變更研究中存在的典型問題，并針對典型問題提出了關(guān)注中藥變更的必要性及合理性、系統(tǒng)全面開展中藥變更研究、完善中藥變更相關(guān)指導(dǎo)原則、加強(qiáng)中西藥復(fù)方制劑變更管理等建議。以期為藥品上市許可持有人開展中藥上市后變更研究和藥監(jiān)部門實(shí)施中藥上市后變更監(jiān)管提供技術(shù)參考。

Post-marketing change of traditional Chinese medicine is an important part of the continuous management of already listed traditional Chinese medicine, which directly affects the safety, effectiveness, and quality controllability of traditional Chinese medicine. However, in the past, post-marketing change of traditional Chinese medicine had problems such as unclear management paths and lack of research and verification, which were not conducive to improving the quality of already listed traditional Chinese medicine. To retrospectively analyze the research data on post-marketing change of traditional Chinese medicines in Fujian Province in the past 10 years, combined with communication cases and review and inspection experiences to sort out the typical problems in the research on post-marketing changes of traditional Chinese medicines, and puts forward suggestions such as paying attention to the necessity and rationality of the changes of traditional Chinese medicines, carrying out the research on changes of traditional Chinese medicines systematically and comprehensively, perfecting the guiding principles related to the changes of traditional Chinese medicines, and strengthening the change management of Chinese and western medicine compound preparations. In order to provide technical reference for marketing authorization holder to carry out post-marketing change research of traditional Chinese medicine and drug supervision departments to implement post-marketing change supervision of traditional Chinese medicine.

R951

福建省藥品監(jiān)督管理局2023年度藥品安全監(jiān)管科研項(xiàng)目（2023023）