Medical products manufactured in Nigeria will, in no time, become acceptable and usable worldwide with immense opportunities for the for both orthodox and traditional practitioners, the National Agency for Food, Drugs and Administration Control (NAFDAC) has assured.
According to the agency’s Director General, Prof. Mojisola Adeyeye, Nigeria is not just celebrating its recent classification as Maturity Level 3 (ML3) Regulatory Authority by the World Health Organisation (WHO), but is already working towards ML4, which would include the endorsement of medical products from Nigeria for sale and use anywhere in the world.
At the briefing of media executives on Tuesday, the NAFDAC DG said that driving towards the attainment of ML 4 emphasised that the goal of the Agency was not to be contend with what is regarded as “African standards”, but to be at par with any regulatory authority globally.
‘At Maturity Level 4, it means that a product that is manufactured in Nigeria has met all the regulatory requirements and can be sold worldwide. That is where we are going. There are no African standards. We have to use international standards, and then we can go to the arena to play with others’, Adeyeye said elatedly.
According to the WHO, National Regulatory Agencies operating at Maturity Level 3 indicates that the system is well-functioning and integrates all required elements to guarantee its stable performance. Nigeria is only one of three African countries in that list, the others being Tanzania (listed in 2018) and Ghana (2020).
The scope of products for which these three countries are classified are medicines and non-producing vaccines.
Although Nigeria’s classifications came on 30th March, this year, it is the most significant for the continent given the size and impact of the country.
‘We are the biggest, everyone is looking up to us. This (certification) brings prestige to Nigeria, that when they are mentioning countries and their regulatory systems, how well functioning they are, they will mention Nigeria’, Adeyeye said.
WHO’s announcement stated that NAFDAC, together with the Pharmacists Council of Nigeria, has “a stable, well-functioning and integrated regulatory system Maturity Level 3 rating scale of the Global Benchmarking Tool (GBT). The ML3 rating is the target of the World Health Assembly Resolution 67.20 for Regulatory System Strengthening to improve capacity of the NRA to regulate medical products in an efficient, effective, and in a transparent manner as buttressed in the Sustainable Development Goal (SDG 3 – Target 3.8) to achieve a universal health coverage and access to safe, effective, quality and affordable essential medicines and vaccines for all”.
With that development, NAFDAC has now been found eligible to be included in the WHO Listed Authorities (WLA). In other words, NAFDAC is among globally-recognised regulatory authorities having met WHO and other international standards.
Adeyeye said that the Agency would not rest on it oars, but rather forged ahead to attain Maturity Level 4 in no distant future.
‘We are not going to stay there. Maturity Level 4 is where we are going. And then specialisation on areas like regulatory inspection and clinical trial, among others. We will then be classified as World Listed Authority by WHO’, she further said.
She spoke about the revolution in herbal medicine which started three years ago when a Herbal Medicine Product Committee was set up, and the fruition of that in due course.
‘God has given us so much; why don’t we tap into it’, she started, and expanded on the synergy that her Agency had established between herbalists and researchers, who initially were skeptical of one another.
‘We will not encourage the use of herbal medicine unless research is conducted. That presented the first challenge we had with the herbalists because they believed they would be letting too much information. We got the herbalists and the researchers together. We developed a confidentiality agreement. We created the synergy’, the DG explained.
She said that the ultimate goal is to have five to 10 herbal medicine products from Nigeria attain global acceptance. ‘This will mean that orthodox doctors can prescribe them. And they can use them, if their patients don’t want Western medicine’, she added.
On COVID-19 containment, the NAFDAC DG said Nigeria would begin the production of vaccines by the end of this year as the government had been working towards local vaccine production even before the pandemic.
‘We are working day and night to ensure that by the end of the year we will start manufacturing our own vaccines, but that does not mean that we will completely develop a vaccine. But the government also has a PPP arrangement with Biovaccines’, Adeyeye explained.
She said that what slowed down the process was the WHO ML 3, without which Nigeria-manufactured vaccines could not be globally certified.
Adeyeye also said that NAFDAC stopped the shipment of more than 80 medicine products from China and India over fraudulent activities by the manufacturers.
