The National Agency for Food and Drug Administration and Control (NAFDAC) has announced measures to strengthen regulatory oversight of blood and blood products in Nigeria, aimed at improving safety and quality across the blood transfusion chain.
The agency said the initiative, supported by the Minister of Health and Social Welfare, Prof. Ali Pate, aligns with global best practices and recommendations of the World Health Organisation (WHO), which classifies blood and blood products as essential medicines requiring effective regulation by national regulatory authorities.
According to a statement signed by NAFDAC Director-General, Prof. Mojisola Adeyeye, and made available to journalists in Abuja, the strengthened regulatory framework will cover the entire blood transfusion process, including donor assessment, blood collection, testing, processing, storage, transportation and clinical use.
Adeyeye described the move as an important step towards strengthening Nigeria’s health system and protecting patients.
She noted that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, already regulate blood products through their national regulatory authorities.
NAFDAC said the development forms part of its ongoing transformation into a modern, science based regulator. The agency noted that it has attained WHO Maturity Level 3 status, completed a WHO Global Benchmarking reassessment and secured WHO prequalification for its drug laboratory.
To support the expanded mandate, NAFDAC said it had established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate.
It added that its laboratory directorate for these products, upgraded from a services unit in 2024, would be responsible for quality control, laboratory testing and lot release, while the Directorate of Evaluation and Research would oversee Good Manufacturing Practices.
The agency also disclosed that it was developing an ultra modern laboratory facility to strengthen the assessment and quality control of vaccines and other biological products.
Adeyeye stressed that effective regulation would require sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
She said NAFDAC remained committed to establishing a robust regulatory framework that would promote the availability of safe, quality assured and efficacious blood and blood products while strengthening public confidence in Nigeria’s healthcare system.
