The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a major breakthrough for Nigeria’s medical manufacturing industry with the World Health Organisation (WHO) pre-qualification of 0.5ml auto-disabled syringes produced by AFRI Medical Manufacturing and Supplies Limited.
NAFDAC Director General, Prof. Mojisola Adeyeye, made the announcement at a press briefing held in Lagos on Wednesday, describing the milestone as “a testament to the success of NAFDAC’s strategies to promote local manufacturing of quality medical products.”
“This feat was not achieved overnight,” Prof. Adeyeye said.
“It is the result of rigorous evaluation, significant investment by AFRI Medical, and sustained guidance and oversight from NAFDAC.
The inclusion of their product in WHO’s list of pre-qualified medical devices makes it eligible for procurement by global health organisations such as UNICEF.”
The pre-qualification represents a significant step forward for Nigeria, granting AFRI Medical access to the global syringe market and enhancing the country’s visibility in international healthcare supply chains.
It also positions Nigeria as a viable manufacturing hub in line with the Federal Government’s industrialisation drive and President Bola Ahmed Tinubu’s emphasis on strengthening local production.
“In keeping with our vision to be a world-class regulator, NAFDAC has adopted global best practices to ensure that only safe and high-quality products are manufactured, imported, and exported,” Prof. Adeyeye said.
She noted that the success is rooted in policy reforms initiated by NAFDAC since 2019, including the “5+5” regulatory directive, which limits continuous importation of products that can be locally manufactured after an initial five-year registration period.
Prof. Adeyeye also reflected on lessons from the COVID-19 pandemic, which exposed Nigeria’s vulnerability to international supply disruptions.
“This prompted a renewed commitment to evaluating and strengthening local manufacturing.
Our assessment of Nigerian-made syringes revealed quality disparities, prompting the launch of a ‘hand-holding’ initiative to assist manufacturers in achieving global compliance,” she said.
The initiative included unannounced facility inspections, field testing, laboratory evaluations, and technical support. According to her, AFRI Medical’s success demonstrates the tangible impact of those efforts.
Mr. Gabi Al-Aridi, General Manager of AFRI Medical, hailed the pre-qualification as “a milestone achievement,” noting that the certification allows the company to export syringes with full WHO, ISO, and market clearance approvals.
“This means AFRI Medical can now supply globally recognised high-quality syringes to UNICEF and other international buyers,” he stated.
Mr. Sheriff Olagunju, a former NAFDAC Director and current staff member of AFRI Medical, echoed the sentiment, praising the rigorous process and collaboration with WHO technical teams.
“The journey has been challenging, but the pre-qualification confirms AFRI Medical’s commitment to international standards and manufacturing excellence.”
The event was attended by senior officials from NAFDAC, directors from relevant departments, and representatives of AFRI Medical, all of whom emphasised the importance of sustained investment and collaboration in Nigeria’s pharmaceutical and medical device sectors.
Prof. Adeyeye concluded with a call to action for local manufacturers: “We are open to working with any local company committed to quality, compliance, and innovation. AFRI Medical is proof that with the right support and dedication, Nigerian manufacturers can meet and exceed global benchmarks.”
