ABUJA — 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, in a move aimed at protecting patients and improving access to safe, quality-assured and affordable blood.

The agency said the initiative would strengthen Nigeria’s healthcare system and reduce the risks associated with unsafe, substandard or poorly handled blood and blood products.

According to NAFDAC, the move has the backing of the Minister of Health and Social Welfare, Prof. Ali Pate, and is consistent with global best practices and World Health Organisation (WHO) recommendations that blood and blood products should be regulated by National Regulatory Authorities (NRAs).

In a statement by its Director-General, Prof. Mojisola Adeyeye, NAFDAC said blood and blood products are classified as essential medicines and must therefore meet consistent standards of quality, safety, efficacy and affordability.

The agency said stronger regulation would cover the entire blood transfusion chain, from donor assessment and blood collection to testing, processing, storage, transportation and clinical use.

NAFDAC Expands Regulatory Capacity

NAFDAC noted that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, already regulate blood and blood products through their national regulatory authorities.

The agency said its renewed focus on blood safety formed part of its broader transformation into a modern, science-based regulatory institution.

It highlighted its attainment of WHO Maturity Level 3, successful completion of the WHO Global Benchmarking Maturity Level 3 reassessment and WHO prequalification of its drug laboratory as evidence of its growing regulatory capacity.

NAFDAC said it had also established internationally accredited laboratory and quality management systems that would provide a strong foundation for regulating blood and blood products.

The agency has established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of relevant biological and medical products.

Its Vaccines, Biologicals and Medical Devices Laboratory Services, which was 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, meanwhile, provides oversight of Good Manufacturing Practices.

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

Collaboration Key to Blood Safety

The agency 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.

It said the regulatory framework would seek to ensure that blood used in Nigerian hospitals meets appropriate safety and quality standards throughout the transfusion process.

NAFDAC assured Nigerians that it would continue working with relevant authorities and stakeholders to establish a robust regulatory system that promotes access to safe, quality-assured and effective blood and blood products.

The agency said the initiative would not only help protect patients from preventable transfusion-related risks but also strengthen public confidence in Nigeria’s healthcare system.