中国药物临床试验机构联盟的建设与实践

Introduction of the development and practice of Chinese good clinical practice union

本文提供我国药物临床机构资格认定检查和机构满3年后进行复核检查中存在各种问题的最新统计,提出借"我国政府进行深化国务院机构改革和职能转变,为全面建成小康社会提供制度保障"的东风,成立社会第三方社会组织—中国药物临床试验机构联盟,为解决药物临床试验行业问题提供有效服务的途径。

This paper summarizes the latest statistics from the evaluation of Chinese clinical trial site qualification and re -inspection 3 years after awarded qualification.Based on the premise of “government deepening of the State Council reform and function transform , providing guarantee for building a comprehensive well -off society”, this paper proposes to es-tablish a real non -government organization-China Good Clinical Prac-tice Union, with purpose of providing services and solutions of the diver-sified issues in drug clinical trial.