National Regulatory Agencies

NRAs are national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines and medical devices including test kits) are evaluated properly and meet international standards of quality and safety and efficacy. All countries need an NRA. Countries manufacturing medical products need to exercise six critical control functions, and they need to exercise them in a competent and independent manner, backed up with enforcement power. Market Authorization and post-marketing surveillance and adverse events following immunization (AEFI) monitoring are functions that all NRAs have to establish regardless of the production capacity, procurement policy i.e.; vaccine locally manufactured, vaccine directly imported or imported through UN procurement agencies. WHO provides technical assistance for the development and implementation of NRA strengthening plans. Support to countries for assessment of their NRA functions is ongoing. Moreover, the Global Training Network on Vaccine Quality (GTN/VQ) is available to provide support in accordance with identified gaps and national plans.

WHO provides technical assistance for the development and implementation of NRA strengthening plans. Support to countries for assessment of their NRA functions is ongoing. Moreover, the Global Training Network on Vaccine Quality (GTN/VQ) is available to provide support in accordance with identified gaps and national plans.