Fabrice COFFRINI / AFP
The World Health Organization (WHO) on Wednesday issued maturity level 3 statuses to Egypt and Nigeria medicines regulators, joining Ghana and Tanzania as countries with effective regulatory systems in Africa.
The maturity level 3 status 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.
Egypt reached achieved the status for vaccines regulation (locally produced and imported), while Nigeria achieved its own for medicines and imported vaccines.
“Egypt and Nigeria have come a long way to improve their regulatory work and performance,” said Mariangela Simao, WHO Assistant Director General for Access to Health Products. “Given that medical products regulatory oversight and manufacturing must work in tandem, this is very good news for access to quality health products on the African continent.”
Regulatory authorities that reach maturity levels 3 and 4 will are eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.
According to the WHO, regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products.
Apart from ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical functions such as faster authorization of products and safety monitoring after authorization.
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