NAFDAC Strengthens Regulation of Blood, Blood Products in Nigeria

By Modupe Gbadeyanka

As part of its efforts to safeguard public health in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has strengthened its regulatory framework for blood and blood products.

A statement signed on Thursday by the Director General of NAFDAC, Prof Mojisola Adeyeye, disclosed that to achieve its goal, the agency will collaborate 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.

NAFDAC said it intends to partner with government institutions, healthcare providers, blood establishments, development partners and other stakeholders for the robust oversight.

Mrs Adeyeye disclosed that already, her organisation has received the support of the Minister of Health and Social Welfare, Prof Ali Pate.

According to her, NAFDAC has been given the mandate to regulate blood and blood products in line with global best practices and the World Health Organisation (WHO) recommendation that these products be subject to oversight by National Regulatory Authorities (NRAs) for medicines.

She said blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety and affordability, stressing that the aim is to protect 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, the NAFDAC chief noted.

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, she added.

Mrs Adeyeye pointed out that NAFDAC’s renewed regulatory preparedness builds on its broader transformation into a modern, science-based regulatory authority.

Already, it has attained WHO Maturity Level 3, completed WHO Global Benchmarking ML3 re-assessment, obtained WHO prequalification for its drug laboratory, and established internationally accredited laboratory and quality management systems. 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, 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 its capacity for the assessment and quality control of vaccines and biologics.