药品注册核查关注的合规风险论述

Compliance Risk Imposed by Drug Registration Inspection

合规风险是启动药品注册核查考虑的重要因素。本文对启动注册核查的合规风险因素及申办者合规管理进行了探讨,并提出第三方专业机构参与药品研发全生命周期合规管理的建议,以期为申办者、研究机构、外包服务机构等研发生产主体应对基于风险的注册核查合规管理提供借鉴。

Compliance risk is an important triggering factor in initiating drug registration inspection.This paper discussed the compliance risk factors of starting registration inspection and the compliance management of sponsors,and proposed that the third-party professional institutions should participate in the compliance management of the whole life cycle of drug research and development,expected to provide reference for sponsors,research institutions,outsourcing service agencies and other R&D and production bodies to cope with the risk-based registration inspection compliance management.