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NAFDAC’s 2025 Roadmap to Strengthen Regulatory Oversight

Regulatory Updates
1. NAFDAC’s 2025 Roadmap to Strengthen Regulatory Oversight
In a bold move t o enhance regulatory oversight and uphold the highest standards within Nigeria’s pharmaceutical and healthcare sectors, the National Agency for Food and Drug Administration and Control (NAFDAC) unveiled its strategic roadmap for 2025 on 16th January. This initiative underscores the agency’s commitment t o ensuring the availability of high-quality, safe, and effective health products in Nigeria.
A key a s p e c t of this roadmap is the institutionalisation of best practices aimed a t securing World Health Organization (WHO) Listed Authority Status. Achieving this status will align Nigeria’s regulatory framework with globally recognised standards, reinforcing consumer confidence i n t h e safety a n d efficacy o f pharmaceutical products circulating within the country.
Another crucial component of the road map i n the implementation of the Pharmaceutical
Inspection Cooperation Scheme (PIC/s) certification. This international certification programme is designed t o enhance inspection standards, ensuring that Nigeria’s pharmaceutical regulatory systems align with leading global practices. By adopting these rigorous inspection protocols, NAFDAC aims to minimise the risk of substandard and falsified medicines entering the market while fostering trust in t h e regulatory process.

Additionally, the roadmap prioritises strengthening Nigeria’s regulatory framework to facilitate seamless access t o high-quality health products. This involves streamlining the approval a n d monitoring processes for pharmaceutical a n d medical products, enhancing post-market surveillance, and reinforcing compliance mechanisms for local and international manufacturers. Through these measures, NAFDAC is working t o create a n enabling environment t h a t supports innovation a n d growth within the pharmaceutical sector while safeguarding public health.
By implementing this strategic roadmap, NAFDAC reaffirms its dedication to advancing pharmaceutical safety and quality assurance in Nigeria. The agency’s efforts reflect a pro active approach to regulatory excellence, ensuring that both healthcare providers and consumers benefit from a more robust a n d transparent regulatory system.

On 16th January, 2025, the National Agency for Food and Drug Administration and Control (NAFDAC) introduced a n ambitious plan to improve regulatory inspections and enhance industry standards.

Key initiatives include
– Institutionalising b e s t practices t o achieve World Health Organization Listed Authority
Status.
– Implementing Pharmaceutical Inspection Cooperation Scheme certification for improved inspection standards.
Strengthening the regulatory framework to ensure access to high-quality health product s .
This strategic roadmap aims to reinforce Nigeria’s commitment to pharmaceutical safety
and quality assurance.

Pamilerin Akabunwa

Deputy Managing Partner at Moroom Africa Legal Consults

Jurisdiction: Lagos


Phone: +2347066435511

Email: pamilerin.akabunwa@moroomafrica.com