The World Health Organization (WHO) announced Wednesday that Egypt’s medical products regulatory agencies had reached maturity level 3, which means that Egypt’s national bodies were found to function well and that they could be eligible for inclusion into the transitional WHO Listed Authorities.
The WHO list will comprise the world’s regulators of reference – that is, regulatory authorities that should be globally recognized as meeting WHO and other international standards, according to a report published by the UN specialized health agency this evening.
“Egypt has reached maturity level 3 for vaccines regulation (locally produced and imported) and Nigeria for medicines and imported vaccines,” the organization said, adding that “the two countries join Ghana and Tanzania as effective regulatory systems on the African continent.”
“Several other African regulators are currently under assessment,” the organization noted.
“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,” the report says.
“Regulatory authorities that reach maturity levels 3 and 4 will be eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance,” the organization pointed out.
It added that “the benchmarking of Egypt and Nigeria’s regulators was carried out by a WHO-led team of international experts. In February and March 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.”
“Egypt and Nigeria were also chosen in February 2022 as recipients of mRNA technology from the WHO mRNA Technology Transfer Hub,” according to the WHO report.
“Effective and efficient regulatory oversight is critical to efforts to boost manufacturing capacity as they ensure that medical products entering the market are safe, effective and produced according to international quality standards,” the organization said.
Meanwhile, Mariangela Simao, WHO Assistant Director General for Access to Health Products, said “Egypt and Nigeria have come a long way to improve their regulatory work and performance.”
“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,” she remarked.
“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” Simao noted.
According to the WHO report, fewer than 30 per cent of the world’s regulatory authorities are considered fully functioning and operational. For that reason, WHO has intensified efforts to bolster the capacity to regulate medical products in all regions.
Source: State Information Service Egypt