為推動和規(guī)范中國放射性診斷藥物的研發(fā)，國家藥品監(jiān)督管理局藥品審評中心于2021年2月發(fā)布了《放射性體內(nèi)診斷藥物非臨床研究技術(shù)指導(dǎo)原則》，著重介紹了放射性診斷藥物非臨床研究的內(nèi)容及特殊考慮，提出了需關(guān)注的受試物特別要求、擴展的單次給藥毒性試驗的適用條件及具體技術(shù)要求，闡述了該類藥物遺傳毒性、生殖毒性、致癌性、輻射安全性評估的考慮因素等。介紹該指導(dǎo)原則起草背景及過程，包括非臨床評價常見問題、經(jīng)業(yè)界討論達(dá)成的基本考慮與共識、征求意見情況，同時還介紹指導(dǎo)原則主要內(nèi)容和關(guān)注點解析，提出指導(dǎo)原則實施的當(dāng)前考慮（非臨床研究時間安排），以促進(jìn)業(yè)界對該指導(dǎo)原則的理解和運用。

In order to promote and regulate the research and development of diagnostic radiopharmaceuticals in China, the Center for Drug Evaluation of National Medical Products Administration issued the "Guidance on non-clinical studies of diagnostic radiopharmaceuticals" in February 2021. This guidance highlighted the content and special considerations of non-clinical studies of diagnostic radiopharmaceuticals, put forward the special requirements for the test article and the applicable conditions and specific technical requirements for the extended single dose toxicity studies, expounded the consideration factors for the evaluation of genotoxicity, reproductive toxicity, carcinogenicity and radiation safety. This article introduces the drafting background and process of the guidance, including common issues in non-clinical evaluation, the basic consideration and congsensus reached through industry discussions, and external solicitation of opinions, and also introduces the guidance's main content and concerns, puts forward the current considerations on the implementation of guidance (time arrangement for non-clinical studies), in order to promote the understanding and application of this guidance in industry.

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