放射性药物临床前研究行业指南概述

辐射防护通讯 ›› 2021, Vol. 41 ›› Issue (5): 44-47.

放射性药物临床前研究行业指南概述

高洁, 周文华, 刘晓明, 刘欢, 王若琪, 尹晶晶, 李建国

中国辐射防护研究院GLP中心,太原,030006

收稿日期:2021-08-26 出版日期:2021-10-20 发布日期:2022-03-31
通讯作者: 李建国,E-mail:ljg2547@163.com
作者简介:高洁(1989—),2015年毕业于山西医科大学药物化学专业,硕士。研究方向为药物毒理与放射性药物安全性评价。
基金资助:
核能开发项目“放射性药物安全性评价关键技术研究”。

Overview of Industry Guidelines for Radiopharmaceutical Preclinical Study

Gao Jie, Zhou Wenhua, Liu Xiaoming, Liu Huan, Wang Ruoqi, Yin Jinjin, Li Jiangguo

GLP Center,China Institute for Radiation Protection,Taiyuan,Shanxi 030006

Received:2021-08-26 Online:2021-10-20 Published:2022-03-31

摘要/Abstract

摘要： 介绍了美国、欧洲以及我国的放射性药物法规管理体系,简述我国放射性药物申报临床研究的流程,对比我国与欧美放射性药物法律法规的异同。

关键词: 放射性药物, 临床前研究, 法规管理体系

Abstract: We introduce radiopharmaceutical regulatory management systems in the United States,Europe and China,describe the process of applying for clinical study of radiopharmaceuticals in China,and compare the legal and regulatory differences and similarities in China with Europe and America in the respect.

Key words: Radiopharmaceuticals, Preclinical study, Regulatory management system

中图分类号:

R818

高洁, 周文华, 刘晓明, 刘欢, 王若琪, 尹晶晶, 李建国. 放射性药物临床前研究行业指南概述[J]. 辐射防护通讯, 2021, 41(5): 44-47.

Gao Jie, Zhou Wenhua, Liu Xiaoming, Liu Huan, Wang Ruoqi, Yin Jinjin, Li Jiangguo. Overview of Industry Guidelines for Radiopharmaceutical Preclinical Study[J]. RADIATION PROTECTION BULLETIN, 2021, 41(5): 44-47.

参考文献

[1] US Food and Drug Administration. Microdose radiopharmaceutical diagnostic drugs: Nonclinical study recommendations guidance for industry[S].2018.
[2] US Food and Drug Administration. Guidance for industry nonclinical evaluation of late radiation toxicity of therapeutic radiopharmaceuticals[S]. 2011.
[3] US Food and Drug Administration. Investigational new drug applications for positron emission tomography (PET) drugs[S]. 2012.
[4] 梁银杏, 叶桦. 关于美国放射性药品注册管理制度的探讨[J]. 中国药事, 2012,26(6): 653-656.
[5] US Food and Drug Administration.The radioactive drug research committee: Human research without an investigational new drug application[S]. 2010.
[6] US Food and Drug Administration. Guidance for industry developing medical imaging drug and biological products conducting safety assessment[S]. 2004.
[7] European Medicines Agency. Guideline on non-clinical-requirements for radiopharmaceuticals [S]. 2018.
[8] ICRP. Radiological protection in therapy with radiopharmaceuticals[R]. 2018.
[9] European Medicines Agency. Concept paper development guidance nonclinical evaluation radiopharmaceuticals[S]. 2017.
[10] European Medicines Agency. Guideline on core SmPC and package leaflet for radiopharmaceuticals[S]. 2011.
[11] European Medicines Agency. Concept paper on the revision of the guideline on radiopharmaceuticals based on monoclonal antibodies[S]. 2009.
[12] 姜典卓. 放射性药品国家标准现状及2015年版《中国药典》中主要增修订内容介绍[J]. 中国药学杂志, 2015, 50(20): 1770-1770.
[13] 国家药品监督管理局. 化学药品注册分类及申报资料要求[S]. 2007.
[14] 国家药品监督管理局. 正电子类放射性药品质量控制指导原则[S]. 2004.
[15] 国家药品监督管理局. 锝〔^99mTc〕放射性药品质量控制指导原则[S]. 2004.