药品不良反应报告和监测管理办法解读及对中药不良反应监测的意义

Interpretation of adverse drug reaction reporting and monitoring and significance of traditional Chinese medicine adverse drug reaction monitoring

新修订的《药品不良反应报告和监测管理办法》于2011年7月1日起实施,这是我国药品不良反应监测工作中最重要的一部法规。该文通过对《办法》内容进行深入的解读,并剖析新办法对中药不良反应监测的指导意义,使新办法的主要修订内容更加明晰,指导中药不良反应监测工作的开展。

The newly revised Regulations for the Administration of Adverse Drug Reaction Reporting and monitoringhas been implemented since July 1, 2011. It is the most important regulation on adverse drug reaction （ADR） monitoring. This article will intensively read the regulation and analysis its significance on the traditional Chinese medicine adverse reaction monitoring, so as to make the revised content more clear and guide the flDR monitoring working better.