The National Agency for Food and Drug Administration and Control (NAFDAC) has said that regulatory framework on blood and blood products in Nigeria is being strengthened 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.

Director-General of NAFDAC, Prof Mojisola Adeyeye who disclosed this in a statement yesterday in Abuja, observed that the move represents an important step in
strengthening Nigeria’s health system and protecting patients throughout the blood transfusion chain.
She noted that blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety and affordability adding that effective regulatory oversight will support the quality and safety of blood products from donor assessment and collection through testing, processing, storage, transportation and use.

Adeyeye stated that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, have already established regulatory oversight of blood and blood products by their NRAS.

According to her, NAFDAC’s renewed regulatory preparedness builds on the Agency’s broader transformation into a modern, science-based regulatory authority.

The NAFDAC boss noted that the Agency has attained WHO Maturity Level 3, successfully completed WHO Global Benchmarking ML3 re-assessment, obtained WHO prequalification for its drug laboratory, and established internationally accredited laboratory and quality management systems.

She said, “These capabilities provide a strong foundation for the effective regulation of blood and blood products. 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 “.

“The Agency established a Vaccines, Biologicals and Medical Devices Laboratory Services many years ago but became a Directorate in 2024 that is responsible for quality control, including laboratory testing and lot release, while the Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices. 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 emphasized that effective regulation of blood and blood products requires sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.

She observed that the Agency remains committed 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.