2 weeks ago
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…Agency acceptable for quality vaccine production
By Chioma Obinna
The Director General of the National Agency for Food and Drug Administration and Control, NAFDAC, Prof. Mojisola Adeyeye, has challenged pharmaceutical manufacturers successful Nigeria to marque bold concern decisions that volition marque the section accumulation of quality vaccines a reality.
She warned that Nigeria indispensable not hold for different pandemic earlier getting prepared, recalling the country’s dependence connected planetary donors during the COVID-19 crisis.
“When COVID-19 struck, we were astatine the mercy of different countries due to the fact that we depended wholly connected overseas supplies for vaccines. That acquisition should ne'er repetition itself,” she said.
According to her, NAFDAC has strengthened its regulatory strategy done a large restructuring process successful enactment with World Health Organisation, WHO, planetary benchmarking standards to pave the mode for vaccine manufacturing successful Nigeria.
“When I came to NAFDAC, the registration of each regulated products—food, drugs, cosmetics, vaccines, aesculapian devices, herbal medicines, pesticides, and others—was nether 1 directorate. That made the strategy inefficient and prone to corruption,” she explained.
“To execute bully governance, we had to make governable units. One manager cannot efficaciously oversee 7 antithetic regulated areas. That was wherefore we separated vaccines and aesculapian devices from the Drug Registration and Regulatory Affairs Directorate.”
Adeyeye disclosed that the bureau achieved WHO Maturity Level 3, ML3, successful 2022 for medicines and imported vaccines, a planetary designation that qualifies it arsenic a functional regulatory authority.
She said that successful November 2024, NAFDAC established a caller Directorate of Vaccines, Biologics, and Medical Devices, pursuing support by the Head of Service of the Federation, to align with planetary champion practices and guarantee effectual oversight.
“For NAFDAC to beryllium benchmarked for vaccines and biologics, we needed a dedicated directorate,” she said. “We are present operating astatine the aforesaid level arsenic precocious countries.”
Expressing optimism that Nigeria volition soon statesman manufacturing its ain vaccines, Adeyeye said:
“It volition beryllium breathtaking quality for maine if, earlier I permission office, Nigeria begins vaccine production. We’ve been producing veterinary vaccines since 1924, yet we inactive beryllium connected overseas countries for quality vaccines. That indispensable change.”
The NAFDAC brag emphasised that immoderate state seeking WHO prequalification for vaccines indispensable person a regulatory strategy with astatine slightest ML3 status.
She noted that Nigeria fulfilled 9 WHO Global Benchmarking Tool modules, with NAFDAC liable for 8 of them, and has achieved ML3 for seven—except for locally manufactured vaccines, which are yet to begin.
“We are moving towards ML3 for locally manufactured vaccines. WHO has verified our vaccine Lot Release indicators; what remains is section vaccine production, which volition let america to transportation retired installation inspections,” she added.
Adeyeye besides revealed that NAFDAC is the lone National Regulatory Agency, NRA, successful sub-Saharan Africa with an in-house laboratory for vaccines, biologics, and aesculapian devices.
“The South African Health Products Regulatory Authority has a vaccines lab, but it’s outsourced. Ours is afloat in-house,” she said.
Speaking further, she urged manufacturers to prehend the moment, noting that President Bola Ahmed Tinubu’s Renewed Hope Agenda encourages section manufacturing crossed sectors.
“We person susceptible scientists and a strengthened regulatory framework. We tin commencement with the ‘Fill and Finish’ signifier portion processing full-scale manufacturing. Now is the clip to get it done,” she asserted.
Corroborating the NAFDAC DG’s position, Mrs. Khadijah Ade-Abolade, Director of Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs, said the national authorities is already playing a strategical relation to guarantee that vaccine accumulation takes disconnected successful Nigeria.
“The regulatory model is already established and functional for imported vaccines, and it volition beryllium applied to locally produced ones erstwhile manufacturing begins,” she explained.
She added that NAFDAC’s regulatory strategy already covers marketplace authorisation, inspection, objective proceedings oversight, post-market surveillance, and pharmacovigilance—all cru...
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