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– We have Strengthened Regulatory System for Vaccines, Biologics, and Medical Devices Through Restructuring and Global Benchmarking.- DG
– Thanks President Bola Ahmed Tinubu, (GCFR,) for encouraging local manufacturing as part of the Renewed Hope Agenda.
By Biola Lawal
The Director General of the National Agency for Food and Drug Administration and Control, NAFDAC, Prof. Mojisola Adeyeye, has charged manufacturers of pharmaceutical products in the country to begin investing in the production of human vaccines locally.
She warned that Nigeria should not wait for another pandemic before it gets prepared and avoid being caught unawares, as witnessed during COVID-19, when the country depended on international donors to survive the scourge.
Prof. Adeyeye made the call in a public statement to pharmaceutical products makers on the urgent need to begin production of vaccines locally with NAFDAC’s success in taken the country to WHO Maturity Level 3 since 2022 and other international recognitions achieved, Sayo Akintola, NAFDAC Media Consultant disclosed.
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Counseling Investors, Prof. Adeyeye stressed:
‘When I came to NAFDAC, we had the Registration and Regulatory Affairs Directorate, which was in charge of registration of all NAFDAC-regulated products, meaning the registration of food, drugs, cosmetics, medical devices, herbal medicines, vaccines, veterinary products, pesticides, and other finished chemicals was under one Director, which made the system susceptible to ineffectiveness and corruption,’ she said.
‘I first carved out the Food Registration and Regulatory Affairs Directorate, and what was left over was still huge,” adding: ”‘if you want good governance and leadership, you must have governable units, governable groups.
” One Director overseeing seven regulated products will not achieve the necessary efficiency. That was why we knew that we had to separate vaccines and medical devices from the Drug Registration and Regulatory Affairs Directorate.
’ NAFDAC became Maturity Level 3 in 2022 for medicines and imported vaccines. For NAFDAC to be benchmarked for vaccines, biologics and medical devices,” Prof. Adeyeye stressed.
She explained further; ”we had to have a separate Directorate headed by a director to ensure that we align with international best practices, and we are operating at the same level as advanced countries of the world.’
The NAFDAC Boss disclosed that the Agency had to separate Vaccines, Biologics, and Medical Devices in November 2024 to form one directorate, following the Head of Service of the Federation’s assessment, evaluation, and sanction, to ensure that it would be a viable Directorate with operating units.
The DG expressed the hope that the nation would manufacture vaccines before she leaves office, saying that ‘It will be exciting news for me, because during the pandemic we were too dependent on foreign countries. We couldn’t get any vaccines unless from outside the country.
” That was when the preparedness for epidemics became a reality for us.’She stated, adding that the Agency now has guidelines for emergency preparedness for epidemics and pandemics.
She however, warned that if there’s another pandemic now and Nigeria is not yet manufacturing human vaccines, despite having manufactured veterinary vaccines since 1924, the country will again be at the mercy of other countries.
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‘During the pandemic, we ran up and down to see whether we could start manufacturing vaccines, but things did not work out,’ she said, adding: ‘we must decide as a country that we will not be too dependent on others. We will manufacture our own.’
According to her,” there has been a movement to do that, but this has not come to reality. ‘That’s why I pray that before my tenure is over, we will be manufacturing vaccines.’
According to her, any country that wants to manufacture vaccines that will be pre-qualified by the WHO must have a regulatory system with at least Maturity Level 3 status.
She added that the fact that we now have ML3 for medicines and imported vaccines in 2022 brought us to the discussion of manufacturing vaccines.
(NAFDAC Operatives in action during an enforcement operation)
She explained that, as a country, we had to fulfil the requirements of nine modules in the WHO Global Benchmarking Tool, one of which is Licensing Establishments for the Pharmacy Council of Nigeria (PCN), and NAFDAC had the remaining eight.
Prof. Adeyeye pointed out that the ML3 we achieved was for seven of the eight, emphasizing that we have not been benchmarked for locally manufactured vaccines.
She noted that NAFDAC is the only National Regulatory Agency (NRA) in sub-Saharan Africa that has an in-house laboratory for vaccines, biologics, and medical devices.
Prof. Adeyeye said that the South African Health Products Regulatory Authority (SAHPRA) has a laboratory for vaccines but contracted it out to private operators.
‘We are working towards getting our ML3 for locally manufactured vaccines. We already have ML3 for medicines and imported vaccines since 2022. WHO came last year, they saw everything that we have as a regulatory agency on indicators for vaccine Lot Release; we have almost satisfied everything except that the country must manufacture vaccines because it’s when we manufacture vaccines that we can do local facility inspections.’
She said NAFDAC has been conducting Lot Release testing on imported vaccines in her lab for years, adding that the WHO wants to know that we can also effectively monitor locally manufactured ones.
‘This is where we are as a country, and I pray that within a short time, we will be able to manufacture our own vaccines.
The Director General further emphasized: ”we have the capability to manufacture vaccines. The country can start with “Fill and Finish” while planning on the greenfield. We have sound scientists.
” We have our President Bola Ahmed Tinubu, GCFR, who is encouraging local manufacturing as part of the Renewed Hope Agenda.
Now is the time to get it done.’ NAFDAC – Safeguarding the Health of the Nation.
Speaking in the same vein, Mrs. Khadijah Ade-Abolade, Director of Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs, stated that the federal government is playing a strategic role to ensure that local vaccine manufacturing takes off in the country.
She stated that the policy has been established, and support is being provided to ensure that vaccine manufacturing takes off in Nigeria.
According to her, the important thing is the regulatory framework, which is already established by NAFDAC and is well-functioning for imported vaccines, and which will also be applied to local vaccines when manufacturing starts in the country.
‘All the required regulatory functions for the regulation of vaccines are already available. We have our market authorisation, which is the registration that we do; the Inspectorate arm of the Agency conducts regulatory inspections.
We have Clinical trial oversight, which is crucial for vaccine regulation, as well as Post-Market Surveillance and Pharmacovigilance, because we need to monitor the safety and efficacy of our vaccines.
Mrs. Ade-Abolade maintained that the regulatory system for local vaccine manufacture is already well established in the country, stressing that ‘We are just waiting for the manufacturing operations to start by the manufacturers.’
(Flowerbudnews)
