再谈体外诊断试剂标准及说明书的起草撰写

Re-reviewing the writing requirements of in vitro diagnosis standard and packaging insert

2010年版《中国药典》三部于2010年10月01日开始执行,该版药典收载了8个按药品管理的体外诊断试剂,其标准在技术要求和规范性方面都有不同程度的提高。为有助于2010年版《中国药典》的顺利实施,文中再谈体外诊断试剂标准和说明书的起草撰写,以期对申报单位有所帮助。

The part III of Chinese Pharmacopeia 2010 edition has been implemented from Oct 1 , 2010 The 8 in vitro diagnosis （IVD） pieces managed as drug are included in it. In Chinese Pharmacopeia 2010 edition, the specification and standardization of products are promoted from different scopes or depth. For smoothly running Chinese Pharmacopeia 2010 e again. This paper is expected dition, to help the writing requirements of IVD standard and packaging insert are emphasized the sponsors or manufacturers of IVD on registration application.