NAFDAC Moves to Strengthen Regulation of Blood Products

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced new measures to strengthen regulatory oversight of blood and blood products across Nigeria, describing the initiative as a major step toward improving patient safety and ensuring access to quality‑assured transfusion services.

The agency said the move aligns with global best practices and follows recommendations from the World Health Organisation (WHO), which classifies blood and blood products as essential medicines requiring strict regulation by national authorities.

NAFDAC’s Director‑General, Prof. Mojisola Adeyeye, said the initiative had received the support of the Minister of Health and Social Welfare, Prof. Ali Pate, and was part of efforts to modernise Nigeria’s regulatory systems.

She said effective regulation would help protect patients from risks associated with unsafe or substandard blood, while strengthening the resilience of the country’s healthcare system.

Agency Expands Oversight Across Entire Blood Transfusion Chain

NAFDAC said the new regulatory framework would cover every stage of the blood transfusion chain, including donor assessment, blood collection, testing, processing, storage, transportation and clinical use.

The agency noted that several African countries — including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda — already regulate blood and blood products through their national authorities, and Nigeria must adopt similar standards to improve safety.

Adeyeye said NAFDAC had already achieved significant milestones, including attaining WHO Maturity Level 3 and completing the WHO Global Benchmarking Maturity Level 3 reassessment.

The agency also obtained WHO pre‑qualification for its drug laboratory, which she described as a strong foundation for regulating blood and biological products.

NAFDAC highlighted the establishment of its Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate, responsible for overseeing the registration and regulation of relevant products.

It also referenced its Vaccines, Biologicals and Medical Devices Laboratory Services, which became a directorate in 2024 and handles quality control activities such as laboratory testing and lot release.

The Directorate of Evaluation and Research provides oversight of good manufacturing practices, ensuring that blood establishments comply with international standards.

NAFDAC further disclosed that an ultra‑modern laboratory facility was being developed to enhance its capacity for assessing vaccines and biological products.

NAFDAC Calls for Collaboration to Ensure Safe Blood Supply

The agency said effective regulation of blood and blood products would require sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.

It assured Nigerians that it would continue working with relevant authorities to establish a robust regulatory framework that promotes the availability of safe, quality‑assured and affordable blood.

NAFDAC said the initiative would help strengthen public confidence in Nigeria’s healthcare system, especially in hospitals where blood transfusion services are critical for emergency care, maternal health and surgical procedures.

Institutions such as the National Blood Service Commission (NBSC) (nbscommission.gov.ng in Bing) have also been pushing for improved standards in blood management nationwide.