通过对我国各地方政府立法情况研究探寻现行《药品管理法》的修订

Through Research Chinese Local Government Legislative to Explore the Current《Drug Administration Law》Amendment

通过对全国各省、自治区、直辖市地方政府立法情况的研究,结合当前药品监管工作的实际,对现行《药品管理法》中有关药物警戒和药品不良反应监测条款进行分析,提出了一些修订意见,旨在全面促进上市后药品安全性监管工作的顺利开展,为药品不良反应监测工作提供更多的法律支持。文章主要从监测体制、加强药品不良反应监测工作制度和报告主体的法律地位及责任等3个方面进行了阐述,并形成初步修订意见。

Through research the local government legislation of the provinces, autonomous regions, and municipalities directly under the condition, analyzed the pharmacovigilance and adverse drug reaction （ADR） monitoring terms of the drug administration law. At the same time this paper combined the actual work of supervision, puts forward some suggestions on revision. In order to promote safety supervision work listed drugs and provide more legal support to ADR monitoring work, this article mainly from the monitoring system, strengthen the ADR monitoring system and report the legal status of main responsibility elaborated, and form the preliminary revision opinion.