Today, WHO announced that Egypt’s and Nigeria’s medical products regulatory agencies had reached maturity level 3. This means that these national bodies have been found to function well and that they could be eligible for inclusion into the transitional WHO Listed Authorities, a list that will comprise the world’s regulators of reference – that is, regulatory authorities that should be globally recognized as meeting WHO and other international standards.

Egypt has reached maturity level 3 for vaccines regulation (locally produced and imported) and Nigeria for medicines and imported vaccines. The two countries join Ghana and Tanzania as effective regulatory systems on the African continent. Several other African regulators are currently under assessment.   

WHO’s assessment of regulatory authorities is based on the ‘ Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 will be eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.