Abstract
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.
Highlights
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
They work within a legal framework and set of regulatory functions spanning the medical product lifecycle, from clinical trial oversight, product marketing authorization and registration, licensing establishments, regulatory inspections, testing products, post-marketing surveillance, and vigilance activities
A well-functioning NRA creates an environment in which medical products are appropriately manufactured, stored, distributed, and dispensed
Summary
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. When a national regulatory system is independent, efficient, science based transparent, and well-managed, it supports robust and effective medical products regulation, and medicines and other health technologies entering the market are safe, efficacious, and of assured quality This in turn protects the population from harm due to unregulated supplies, including substandard and falsified medical products, and fosters confidence in the health care delivery system. It ensures that health professionals and patients are in a position to use medical products rationally because they have the information they need to do so, and ensures promotion and advertising is fair and balanced It supports local production of medical products, which is key to affordability, helps create a transparent, and well-organized market for pharmaceuticals and other medical products, and enables post-marketing surveillance and integrity of the supply chain. Effective regulatory systems are an essential component of health systems and contribute significantly to universal health coverage
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