摘要
世界卫生组织预认证项目通过对药品安全性、质量与功效方面的审查与认证,致力于为处于贫困之中的人提供优质且低廉的药品.拥有预认证项目的药品能够更快地进入发展中国家市场,也能够获得联合国等国际机构采购清单的入场券.然而,目前对于预认证项目的研究大多停留在技术层面,侧重于申请流程等分析,缺少从国际政治维度的分析.加深对于预认证项目的认识不仅能够促进对全球公共卫生治理的理解,也能够为中国药企国际化提供帮助.本文基于国际机制的视角,探讨预认证项目的合法性、有效性与局限性.
World Health Organization Prequalification Programme aims to provide quality and affordable medicines to people in poverty by examining and certifying medical products'safety,quality and efficacy.The products entering the PQ lists could reach the market in developing countries more quickly,also gain the access to the purchasing lists of relevant UN agencies or international organizations.However,current research on PQ stays at the techmical level,focusing on how to apply PQ.A profound understanding of PQ will give an insight into global public health governance,as well as inspire China's pharmaceutical companies to internationalize.This essay analyses PQ's legitimacy,effectiveness and limitations from an international regime perspective.
关键词
世界卫生组织预认证项目
国际机制
合法性
有效性
局限性
World Health Organization Prequalification Programme
International regime
Legitimacy
Effectiveness
Limitations
