从新修订《药品注册管理办法》谈IV期临床试验管理

The New Amendment "Drugs Registered Management Measures" to Discuss the IV Clinical Trial Management

为保证药品的安全、有效和质量可控,规范药品注册行为,新修订的《药品注册管理办法》于2007年10月1日起正式施行。其中,IV期临床试验作为药品注册管理的重要内容,在新修订的《药品注册管理办法》的规定和实际工作中存在诸多值得研究的问题。通过对新修订的《药品注册管理办法》及相关法律、法规中有关IV期临床试验规定及现实操作的探讨与分析,加深对《药品注册管理办法》的理解,以期为完善《药品注册管理办法》和规范IV期临床试验提供借鉴。

To ensure the safety use of drug, effective and quality controlled and standardized drug registration, the newly revised ＂Drug Registration Management Measures＂ in the October 1, 2007 onwards pur-poses. Drug registration of IV clinical trials as an important part of the management, and related laws and regulations in the newly revised ＂Drug Registration Management Measures＂ and the provisions of the actual work there are still many issues to be studied In this pape the newly revised ＂Drug Regis-tration＂ and the relevant laws and regulations related to Ⅳ clinical trial requirements and to explore practical and operational analysis, the ＂Drug Registr Management Measures＂ better understanding and improvement of some of the views and suggestions put forward, and Readers questionable.