AFRICA – Egypt’s and Nigeria’s medical products regulatory bodies have been formally certified by the World Health Organization (WHO) as Maturity Level Three Regulatory agencies to oversee local manufacturing.
With the certification, the Egyptian Drug Authority now has the greenlight to regulate locally produced and imported vaccines.
On the other hand, Nigeria’s National Agency for Food and Drug Administration and Control will now oversee the regulation of medicines and imported vaccines including the much needed COVID-19 vaccines.
The national bodies will provide effective and efficient regulatory oversight in an effort to boost manufacturing capacity and access to quality health products in Africa.
They will also ensure that medical products entering the market are safe, effective and produced according to international quality standards.
The agencies can now be considered for inclusion into the transitional WHO-Listed Authorities that meet the health organization’s standards as well as international standards for reference by other drug regulators.
Regulatory authorities that reach maturity levels 3 and 4 are eligible for inclusion among WHO-listed authorities after additional evaluation of their performance.
Other African countries with effective regulatory systems include Ghana and Tanzania with several other African regulators which are currently under assessment.
According to WHO, the assessment is based on the Global Benchmarking Tool that checks regulatory functions against a set of more than 260 indicators to establish their level of maturity and functionality.
The indicators cover core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events.
The WHO-Listed Authorities provide an evidence-based design for regulatory authorities to be globally recognized as meeting and applying WHO, other internationally recognized standards and guidelines as well as good regulatory practices.
A WHO-led team of international experts carried out the formal evaluation of Egypt and Nigeria’s regulators between February and March 2022 when they found the authorities to perform well against most indicators in the Global Benchmarking Tool.
WHO Assistant Director General for Access to Health Products Mariangela Simao reaffirmed that regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products.
Mariangela Simao further said that well-functioning regulatory authorities also perform critical functions in the health sector such as faster authorization of products and safety monitoring after authorization.
Earlier, Egypt and Nigeria were also chosen in February 2022 as recipients of mRNA technology from the WHO Technology transfer hub.
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