Nigeria is one step away from achieving a higher World Health Organisation (WHO) regulatory benchmark for medicines and vaccines, a development that could strengthen confidence in the country’s pharmaceutical industry.
The National Agency for Food and Drug Administration and Control (NAFDAC) said Nigeria has fulfilled eight of the nine regulatory requirements needed for full benchmarking, with vaccine lot release remaining the major outstanding function.
The remaining gap is largely linked to the country’s limited local capacity for manufacturing human vaccines.
Nigeria currently operates at WHO Maturity Level 3, which indicates that its regulatory system is stable and functional. The next level, Maturity Level 4, represents an advanced regulatory system with a focus on continuous improvement.
The achievement is significant because having vaccine manufacturing plants is only one part of building a strong local vaccine industry. Manufacturers and international procurement organisations also need confidence that vaccines produced in the country are consistently tested, approved and monitored according to recognised safety and quality standards.
A stronger regulatory system could therefore help Nigeria attract more pharmaceutical investment, support local vaccine production and reduce the country’s dependence on imported vaccines, particularly during global supply shortages.
However, the outstanding requirement highlights a major challenge: Nigeria needs sufficient local vaccine production for its regulatory authorities to fully demonstrate their ability to oversee vaccine manufacturing.
The development therefore places both regulatory improvement and local manufacturing capacity at the centre of Nigeria’s ambition to become more self-reliant in vaccine production.
If the remaining gap is addressed, Nigeria could move closer to building a vaccine industry that is not only locally produced but also trusted internationally.
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