The National Agency for Food and Drug Administration and Control (NAFDAC) is set to strengthen the regulation of blood and blood products in Nigeria as part of efforts to improve safety and protect patients.
The agency said it has received the backing of the Minister of Health and Social Welfare, Prof. Ali Pate, to align Nigeria’s regulatory framework with global best practices and World Health Organisation (WHO) recommendations.
According to a statement signed on Thursday, NAFDAC Director-General, Prof. Mojisola Adeyeye, said blood and blood products are classified as essential medicines and must be consistently available while meeting required standards of quality, safety and affordability.
Adeyeye said stronger regulatory oversight would help safeguard the entire blood transfusion chain, from donor assessment and collection to testing, processing, storage, transportation and clinical use.
“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.
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She noted that countries including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda have already introduced regulatory oversight of blood and blood products through their National Regulatory Authorities.
The NAFDAC chief said the agency’s renewed focus builds on its ongoing transformation into a modern, science-based regulatory authority.
She highlighted NAFDAC’s attainment of WHO Maturity Level 3, successful completion of the WHO Global Benchmarking ML3 reassessment, WHO prequalification of its drug laboratory and the establishment of internationally accredited laboratory and quality management systems.
According to her, these achievements provide a strong foundation for regulating blood and blood products effectively.
As part of its preparedness, NAFDAC has also established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of biological products.
Adeyeye said the agency’s Vaccines, Biologicals and Medical Devices Laboratory Services, established several years ago and upgraded to a directorate in 2024, is responsible for quality control activities, including laboratory testing and lot release.
The Directorate of Evaluation and Research, she added, provides oversight of Good Manufacturing Practices as the agency moves to strengthen Nigeria’s blood and blood products regulatory system.
