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治疗绝经后骨质疏松症创新药临床试验技术指导原则（2021年）

2021-01-14 国家药品监督管理局药品审评中心（CDE） NMPA

骨质疏松症

为鼓励用于治疗绝经后骨质疏松症创新药临床研发，进一步规范和指导临床试验设计，提供可参照的技术规范，在国家药品监督管理局的部署下，药审中心组织制定了《治疗绝经后骨质疏松症创新药临床试验技术指导原则》（见

中文标题：

治疗绝经后骨质疏松症创新药临床试验技术指导原则（2021年）

发布机构：

国家药品监督管理局药品审评中心（CDE）

发布日期：

2021-01-14

简要介绍：

为鼓励用于治疗绝经后骨质疏松症创新药临床研发，进一步规范和指导临床试验设计，提供可参照的技术规范，在国家药品监督管理局的部署下，药审中心组织制定了《治疗绝经后骨质疏松症创新药临床试验技术指导原则》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。
       特此通告。
                                                                                                                           国家药品监督管理局药品审评中心
                                                                                                                                         2021年1月14日

相关资料下载：
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    2022-04-26 su_yi_fei

    ***

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    2021-02-13 freesimon

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