The National Agency for Food and Drug Administration and Control (NAFDAC) has announced plans to strengthen its regulatory framework for blood and blood products in Nigeria.
NAFDAC confirmed that it has received the support of the Minister of Health and Social Welfare, Prof. Ali Pate, in line with global best practices and the World Health Organization (WHO) recommendation that these products be subject to oversight by National Regulatory Authorities (NRAs) for medicines.
According to a statement signed on Thursday, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, noted that blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety, and affordability.
Prof. Adeyeye explained that the move represents an important step towards strengthening Nigeria’s health system and protecting patients throughout the blood transfusion chain.
“Effective regulatory oversight will support the quality and safety of blood products from donor assessment and collection through testing, processing, storage, transportation and use,” she said.
She pointed out that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal, and Rwanda, have already established regulatory oversight of blood and blood products through their NRAs.
The DG stressed that NAFDAC’s renewed regulatory preparedness builds on the Agency’s broader transformation into a modern, science-based regulatory authority.
Adeyeye disclosed that the Agency had attained WHO Maturity Level 3, successfully completed the WHO Global Benchmarking ML3 re-assessment, obtained WHO prequalification for its drug laboratory, and established internationally accredited laboratory and quality management systems.
She stated that these capabilities provide a strong foundation for the effective regulation of blood and blood products.
Adeyeye revealed that, as part of its preparedness, NAFDAC has established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of these products.
She also disclosed that the Agency established its Vaccines, Biologicals and Medical Devices Laboratory Services many years ago, and that it became a Directorate in 2024. The Directorate is responsible for quality control, including laboratory testing and lot release, while the Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices.
She affirmed that an ultra-modern laboratory facility is also being developed to further strengthen the Agency’s capacity for the assessment and quality control of vaccines and biologics.
Adeyeye further acknowledged that effective regulation of blood and blood products requires sustained collaboration among government institutions, healthcare providers, blood establishments, development partners, and other stakeholders.
She reiterated the Agency’s committment to working with relevant authorities and stakeholders to establish a robust regulatory framework that promotes the availability of safe, quality-assured, and efficacious blood and blood products, while strengthening public confidence in Nigeria’s healthcare system.
