Nigeria, Egypt Reach WHO’s Maturity Level on Medical Products

Egypt and Nigeria’s medical products regulatory agencies, were announced by the World Health Organisation (WHO) to have reached maturity level 3. The meaning of this is that these national bodies have been found to function well and might be eligible for an inclusion into the transitional WHO Listed Authorities, a list that will comprise of the world’s regulators of reference that is, regulatory authorities that should be globally recognised as meeting WHO and other international standards.

A report from WHO said that Egypt had reached maturity level 3 for its vaccines regulation (both locally produced and imported) and Nigeria for its medicines and imported vaccines. The two countries have both joined Ghana and Tanzania as effective regulatory systems on the African continent. Other African regulators are also currently under assessment. WHO’s assessment of the regulatory authorities are based on the ‘Global Benchmarking Tool’ – this is an evaluation tool that checks regulatory functions against a set of over 260 indicators – it covers core regulatory functions such as product authorisation, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality.

Regulatory authorities that have reached maturity levels 3 and 4 will be eligible for an inclusion among the WHO-listed authorities, after an additional evaluation of their performance. The benchmarking of Egypt and Nigeria’s regulators was carried out by a WHO-led team of international experts. In February and March of 2022, WHO conducted a formal evaluation of the authorities and found them to perform well against most of the indicators in the Global Benchmarking Tool.

In February 2022, Nigeria and Egypt were chosen as the recipients of mRNA technology from the WHO mRNA Technology Transfer Hub. Effective and efficient regulatory oversight is critical to the efforts to boost manufacturing capacity as they ensure that the medical products entering the market are safe, effective and produced according to international quality standards.

“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.”

Regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products. Aside from ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well can also perform critical functions such as faster authorisation of products and safety monitoring after authorisation. Less than 30 per cent of the world’s regulatory authorities are considered fully functioning and operational.

For this exact reason, WHO has intensified its efforts to bolster the capacity to regulate medical products in all regions. WHO has also announced a transitional WHO-Listed Authorities (WLAs) list. This is the introduction of a framework for designating and publicly listing a regulatory authority as a WLA aims to provide a transparent and evidence-based pathway for regulatory authorities to be globally recognised as meeting and applying WHO and other internationally recognized standards and guidelines, as well as good regulatory practices