Drugs manufactured in Nigeria can now compete globally – experts

Drugs produced in Nigeria and regulated by the National Agency for Food Drug and Administration Control (NAFDAC) can favourably compete in the international market following the certification of NAFDAC as Maturity Level 3 regulatory agency by the World Health Organisation (WHO), experts have said.

The WHO announced that Egypt and Nigeria’s medical products regulatory agencies have reached maturity level 3. This means that Nigeria has been found to function well and could be eligible for inclusion in the transitional WHO Listed Authorities; a list comprising world’s regulators of reference – that is, regulatory authorities that should be globally recognised as meeting WHO and other international standards.

While Egypt reached maturity level 3 for vaccines regulation (locally produced and imported), Nigeria on the other hand, is 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.

Ebirim Obinna, a public health consultant and health promotion specialist, said with the development, drugs produced in Nigeria and certified by NAFDAC to be of good quality would be better respected by other countries and compete globally.

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The expert added that pharmaceutical firms in Nigeria would be internationally recognised and clinical trials conducted in the country stand a better chance of being globally recognised.

“Excitingly, we can now begin local vaccine production. I conducted an assessment on why Nigeria cannot produce vaccines locally, and failure of the country to attain maturity level 3. But this certification will boost production of pharmaceuticals which can impact positively on the economy,” he said.

The director-general, NAFDAC, Mojisola Adeyeye at a media briefing said the certification also means that NAFDAC laboratories are functioning at the required capacity and that Nigeria can confidently produce drugs.

Adeyeye said the certification was an indication that Nigeria has now improved in clinical trials, produced world standard guidelines and procedures, increased regulatory inspection, laboratory listings, market control, and other regulatory operations.

The DG also said the maturity level 3 has strengthened NAFDAC’s move for manufacturing of vaccines locally, including the COVID-19 vaccine. She informed that the laboratory being built in Oshodi, Lagos State, would be ready by the middle of this year or first week of the third quarter. NAFDAC had got N4 billion to equip the facility.

Recall that Nigeria was also chosen in February 2022 as recipients of mRNA technology from the WHO mRNA Technology Transfer Hub. The WHO noted that 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.

On how NAFDAC achieved the status, the DG said the agency scaled through 868 recommendations, akin to tests before it attained the maturity level 3 stage, informing that the WHO had conducted physical examinations of NAFDAC facilities and systems before issuing the certification.

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 authorisation, 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 level 3 and 4 will be eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.