中国《放射性体内诊断药物非临床研究技术指导原则》解读

Interpretation to guidance on non-clinical studies of diagnostic radiopharmaceuticals

为推动和规范中国放射性诊断药物的研发,国家药品监督管理局药品审评中心于2021年2月发布了《放射性体内诊断药物非临床研究技术指导原则》,着重介绍了放射性诊断药物非临床研究的内容及特殊考虑,提出了需关注的受试物特别要求、扩展的单次给药毒性试验的适用条件及具体技术要求,阐述了该类药物遗传毒性、生殖毒性、致癌性、辐射安全性评估的考虑因素等。介绍该指导原则起草背景及过程,包括非临床评价常见问题、经业界讨论达成的基本考虑与共识、征求意见情况,同时还介绍指导原则主要内容和关注点解析,提出指导原则实施的当前考虑(非临床研究时间安排),以促进业界对该指导原则的理解和运用。

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.