NAFDAC Tightens Grip on Blood, Blood Products

"The initiative followed the support of the Minister of Health and Social Welfare, Prof. Ali Pate, and aligns with the World Health Organisation (WHO) recommendation that blood and blood products be subjected to oversight by national medicines regulatory authorities." NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has stepped up regulatory oversight of blood and blood products in Nigeria, in a move aimed at ensuring the safety, quality and availability of products used in blood transfusion.

The agency said the initiative followed the support of the Minister of Health and Social Welfare, Prof. Ali Pate, and aligns with the World Health Organisation (WHO) recommendation that blood and blood products be subjected to oversight by national medicines regulatory authorities.

According to NAFDAC, effective regulation will cover the entire blood transfusion chain, including donor assessment and collection, testing, processing, storage, transportation and eventual use.

The agency described blood and blood products as essential medicines that must be consistently available, affordable and assured of quality and safety, stressing that stronger regulatory controls would help protect patients and strengthen confidence in Nigeria’s healthcare system.

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 respective national regulatory authorities.

The Director-General of NAFDAC, Prof. Mojisola Adeyeye, said the agency’s renewed preparedness was anchored on its broader transformation into a modern, science-based regulatory authority.

She noted that NAFDAC had attained WHO Maturity Level 3, successfully completed the WHO Global Benchmarking Maturity Level 3 reassessment and obtained WHO prequalification for its drug laboratory.

The agency also disclosed that it had established internationally accredited laboratory and quality management systems, which it said provided a strong foundation for regulating blood and blood products effectively.

As part of the preparedness, NAFDAC said it had established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of relevant products.

The agency explained that its Vaccines, Biologicals and Medical Devices Laboratory Services, established several years ago, was upgraded to a directorate in 2024 and is responsible for quality control activities, including laboratory testing and lot release. The Directorate of Evaluation and Research, it added, provides oversight of Good Manufacturing Practices.

NAFDAC further disclosed that an ultra-modern laboratory facility was being developed to strengthen its capacity to assess and conduct quality control of vaccines and biological products.

Adeyeye stressed that 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 to establish a robust regulatory framework that would promote access to safe, quality-assured and efficacious blood and blood products while strengthening public confidence in Nigeria’s healthcare system.