The National Agency for Food and Drug Administration and Control (NAFDAC) has announced plans to strengthen regulatory oversight of blood and blood products in Nigeria as part of efforts to safeguard patients and improve safety across the blood transfusion chain.
The Agency said the move had received the support of the Minister of Health and Social Welfare, Prof. Ali Pate, and was in line with World Health Organisation (WHO) recommendations that blood and blood products should be subject to regulatory oversight by national medicines regulatory authorities.
NAFDAC made this known in a statement signed by its Director-General and Chief Executive Officer, Prof. Mojisola Adeyeye.
According to the Agency, blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety and affordability.
It said effective regulatory oversight would strengthen the quality and safety of blood products at every stage — from donor assessment and blood collection through testing, processing, storage, transportation and eventual use.
NAFDAC noted that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, had already established regulatory oversight of blood and blood products through their national regulatory authorities.
The Agency said its renewed regulatory preparedness was built on its broader transformation into a modern, science-based regulatory authority.
It pointed to its attainment of WHO Maturity Level 3, successful completion of a WHO Global Benchmarking Maturity Level 3 reassessment, WHO prequalification of its drug laboratory, as well as internationally accredited laboratory and quality management systems.
According to NAFDAC, these capabilities provide a strong foundation for effective regulation of blood and blood products.
As part of its preparedness, the Agency said it had established a dedicated Vaccines, Biologics and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of these products.
It explained that its Vaccines, Biologics and Medical Devices Laboratory Services, established several years ago, became a Directorate in 2024 and is responsible for quality control functions, including laboratory testing and lot release.
The Directorate of Evaluation and Research, it added, provides oversight of Good Manufacturing Practices.
NAFDAC also disclosed that an ultra-modern laboratory facility was being developed to further strengthen its capacity for the assessment and quality control of vaccines and other biological products.
Adeyeye said effective regulation of blood and blood products would require sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
She assured that NAFDAC remained committed to working with relevant authorities and stakeholders to establish a robust regulatory framework capable of promoting the availability of safe, quality-assured and efficacious blood and blood products.
The Agency said the initiative was also intended to strengthen public confidence in Nigeria’s healthcare system.
The move is particularly significant because the safety of blood transfusion depends not only on the availability of donated blood but also on the integrity of the entire chain through which blood and blood products are collected, tested, processed, stored, transported and administered.
By strengthening regulatory oversight across that chain, NAFDAC said it was seeking to ensure that patients receive blood and blood products that meet appropriate standards of quality and safety.
