Definition:

An NRA is an entity which has the mandate to ensure the quality, safety and efficacy of medicines, vaccines, blood, and blood products as well as medical devices, including diagnostics and traditional, or herbal medicines that are distributed in a country.   

The entity is responsible for regulatory oversight of these products and safeguarding the country’s public health by ensuring that these products are appropriately evaluated and meet international standards of quality, safety, and efficacy, as well as ensuring the relevance and accuracy of medicinal product information.  

More information:

National regulatory agencies (NRAs) (WHO, 2024)

The World Health Organization global benchmarking tool an instrument to strengthen medical products regulation and promote universal health coverage (Frontiers in Medicine, 2020)

Tags:
Definition, Encyclopaedia, CMC, Discovery, Phase 1, Phase 2, Phase 3, Phase 4, Preclinical development, Regulatory