The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage

Frontiers in Medicine

article

Alireza Khadem Broojerdi¹  Hiiti Baran Sillo¹  Razieh Ostad Ali Dehaghi¹  Mike Ward¹  Mohamed Refaat¹  Jane Parry² 

[1] Regulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization;Specialist Public Health Writer

关键词: global benchmarking tool;    GBT;    regulatory systems strengthening;    regulation;    regulation of medical products;    national regulatory authority;    RSS;    NRA;   

DOI  :  10.3389/fmed.2020.00457

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY