The National Agency for Food and Drug Administration and Control (NAFDAC) has unveiled plans to strengthen the regulation of blood and blood products in Nigeria, a move aimed at improving patient safety and ensuring higher standards across the country’s blood transfusion system.

The agency said the initiative forms part of broader efforts to align Nigeria’s healthcare system with international best practices and guarantee that blood products supplied to patients meet strict quality and safety requirements.

In a statement issued in Abuja on Thursday, NAFDAC Director-General, Prof. Mojisola Adeyeye, said the renewed regulatory drive followed recent backing from the Minister of Health and Social Welfare, Prof. Muhammad Pate, and reflects global recommendations by the World Health Organization (WHO).

According to Adeyeye, blood and blood products are recognised worldwide as essential medicines and should be subjected to rigorous oversight to ensure they remain safe, effective, accessible and affordable for patients who depend on them.

She noted that strengthening regulatory control over the sector would help safeguard every stage of the blood transfusion process, from donor screening and blood collection to testing, processing, storage, transportation and final use in healthcare facilities.

The NAFDAC chief described the development as a significant milestone in ongoing efforts to improve healthcare delivery and protect Nigerians from risks associated with unsafe blood products.

She pointed out that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, have already placed blood and blood products under the supervision of their national medicines regulatory authorities.

Adeyeye said Nigeria is now taking decisive steps to strengthen its own framework, leveraging NAFDAC’s growing capacity as a science-driven regulatory institution.

According to her, the agency’s preparedness is supported by a series of recent achievements, including attaining the World Health Organization’s Maturity Level Three (ML3) status and successfully completing a re-assessment under the WHO Global Benchmarking Tool.

She added that NAFDAC has also secured WHO prequalification for one of its drug testing laboratories and established internationally accredited quality management systems, developments she said have significantly enhanced the agency’s regulatory capabilities.

Advertisement

“These achievements provide a strong foundation for the effective oversight of blood and blood products and position the agency to meet international regulatory standards,” she stated.

As part of the reforms, NAFDAC has strengthened its institutional structure by creating a dedicated Directorate for Vaccines, Biologicals and Medical Devices Registration and Regulation to oversee the approval and monitoring of blood products and other biological materials.

Adeyeye explained that while the agency had operated a laboratory unit for vaccines, biologicals and medical devices for several years, the unit was upgraded to a full-fledged directorate in 2024 to expand its responsibilities and improve efficiency.

The directorate is expected to play a critical role in quality assurance through laboratory testing, product evaluation and lot-release activities before blood products are cleared for use.

She also disclosed that the agency’s Directorate of Evaluation and Research would continue to monitor compliance with Good Manufacturing Practices, while an ultra-modern laboratory currently under development would further enhance NAFDAC’s capacity to assess vaccines and biological products.

Despite the progress made, Adeyeye stressed that effective regulation of blood products cannot be achieved by government alone.

She called for stronger collaboration among healthcare institutions, blood banks, government agencies, development partners and other stakeholders to ensure a safe and reliable blood supply system nationwide.

According to her, NAFDAC remains committed to building a comprehensive regulatory framework that guarantees the availability of quality-assured blood and blood products while boosting public confidence in Nigeria’s healthcare system.

The move is expected to strengthen patient protection, reduce risks associated with blood transfusion and support broader efforts to improve healthcare outcomes across the country.