Khadem Broojerdi Alireza, Baran Sillo Hiiti, Ostad Ali Dehaghi Razieh, Ward Mike, Refaat Mohamed, Parry Jane
Regulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization, Geneva, Switzerland.
Specialist Public Health Writer, Hamilton, ON, Canada.
Front Med (Lausanne). 2020 Aug 19;7:457. doi: 10.3389/fmed.2020.00457. eCollection 2020.
National regulatory authorities (NRAs) are the gatekeepers of the supply chain of medical products, and they have a mandate to ensure the quality, safety and efficacy of medicines, vaccines, blood, and blood products, medical devices, including diagnostics and traditional, or herbal medicines. However, the majority of the world's regulators are still struggling to reach a level of maturity, whereby they have a stable, well-functioning and integrated regulatory system. The World Health Organization (WHO) has developed a Global Benchmarking Tool (GBT) as part of its five-step capacity building program to assist NRAs, using the tool, they can benchmark their own strengths and areas of weakness, and then engage in a formal benchmarking process together with WHO and international experts in order to formulate an effective and workable institutional development plan. The GBT is comprehensive across the entire product life cycle and allows benchmarking to be customized to the needs of the NRA. It has evolved from decades of experience using a variety of benchmarking tools, within WHO and other stakeholder organizations. By the end of December 2019, 26 countries had undergone formal benchmarking, and a further 54 countries had used the GBT to conduct self-benchmarking exercises assisted by WHO.
国家监管当局是医疗产品供应链的把关者，其职责是确保药品、疫苗、血液及血液制品、医疗设备（包括诊断产品）以及传统或草药的质量、安全和有效性。然而，世界上大多数监管机构仍在努力达到成熟水平，即拥有稳定、运作良好且整合的监管体系。世界卫生组织（WHO）开发了全球基准工具（GBT），作为其五步能力建设计划的一部分，以协助国家监管当局。利用该工具，他们可以衡量自身的优势和薄弱环节，然后与WHO及国际专家一起参与正式的基准评估过程，以制定有效且可行的机构发展计划。GBT在整个产品生命周期中具有全面性，并允许根据国家监管当局的需求进行定制基准评估。它是基于WHO及其他利益相关组织数十年使用各种基准工具的经验而发展而来的。截至2019年12月，已有26个国家接受了正式基准评估，另有54个国家在世卫组织的协助下使用GBT进行了自我基准评估。
