Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania.
Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania.
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DOI：
10.1136/bmjgh-2020-003043
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发表时间：
2021-05
影响因子：
8.1
通讯作者：
Hampshire K
中科院分区：
文献类型：
--
作者：
Hamill H;David-Barrett E;Mwanga JR;Mshana G;Hampshire K
2012年，世卫组织启动了针对不合格和伪造药品的全球监测和监测系统（GSMS），目的是提高报告质量，并利用数据为上市后监测提供信息，建设监管能力。然而，从监管治理的角度来看，其有效性取决于"实地“行为者查明、报告和调查可能的违规行为并执行处罚的意愿和能力。本文介绍了27个负责监管药品市场的机构代表和4个坦桑尼亚制药行业代表的采访结果。他们的经验提供了重要的见解，说明报告与减少不良行为之间的理论机制如何在低收入背景下发挥作用，揭示了关于监管行为和动机的隐藏假设。长期资源不足、信息差距和执法挑战的结合，限制了当地监管机构实现全球安全管理体系目标的努力，使人们对明显的“不当行为”和结构性限制之间的关系有了新的认识。
In 2012, the WHO launched its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, with the aim of improving the quality of reporting and using the data to inform post-market surveillance and build regulatory capacity. However, from a regulatory governance perspective, its effectiveness depends on the willingness and ability of actors ‘on the ground’ to identify, report and investigate possible infringements and to enforce penalties. This paper presents findings from 27 interviews with representatives of agencies charged with regulating pharmaceutical markets and 4 interviews with pharmaceutical industry representatives in Tanzania. Their experiences provide important insights into how the theorised mechanism between reporting and a reduction in undesirable behaviours can play out in a low-income context, revealing hidden assumptions about regulator behaviour and motivations. A combination of chronic under-resourcing, information gaps and enforcement challenges conspires to limit the efforts of local regulators to achieve the GSMS goals, shedding new light on the relationship between apparent ‘misconduct’ and structural constraints.
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影响因子：
6.2
作者：
Janssen, Marijn;Charalabidis, Yannis;Zuiderwijk, Anneke
通讯作者：
Zuiderwijk, Anneke
影响因子：
8.2
作者：
BECKER, GS
通讯作者：
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影响因子：
0.7
作者：
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通讯作者：
Cawood, Ian
DOI：
10.1146/annurev-polisci-032210-144356
发表时间：
2014-01-01
期刊：
ANNUAL REVIEW OF POLITICAL SCIENCE, VOL 17
影响因子：
--
作者：
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通讯作者：
Fung, Archon
影响因子：
2.8
作者：
Kingori, Patricia;Gerrets, Rene
通讯作者：
Gerrets, Rene