A Rude but Necessary Awakening: COVID-19 and the Role of Regulatory Agencies in Africa

A Rude but Necessary Awakening: COVID-19 and the Role of Regulatory Agencies in Africa

{Pharmacist Mary Yeesuf dispenses medicine to a patient in Minna, Nigeria. Photo Credit: Gwenn Dubourthournieu}Pharmacist Mary Yeesuf dispenses medicine to a patient in Minna, Nigeria. Photo Credit: Gwenn Dubourthournieu

Q&A with Professor Mojisola Christianah Adeyeye

COVID-19 has highlighted the need for long-term investments in regulatory systems to secure faster access to medical products. During a recent Livestream hosted by MSH and Deloitte, Professor Mojisola Christianah Adeyeye, Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), emphasized the role regulatory agencies play in ensuring pharmaceutical system impact now and beyond the pandemic. One such breakthrough─local manufacturing─requires agencies shore up regulatory capacities and address challenges now. Prof. Adeyeye discusses how her agency supports the local manufacturing of medicines and prepares for the roll-out of vaccines against COVID-19.

 

How has COVID-19 helped advance investments in regulation and local manufacturing of essential medical products in Nigeria? 

 

COVID-19 brought a rude but sound awakening to Nigeria─due to the disruption in the supply chain and restricted travel and lockdown. We were stung very badly at the beginning of the pandemic since India shut its doors and our overdependence on imports became magnified. Right now, Nigeria manufactures only 30% of our products locally and imports 70%. Our goal is to drastically flip this to 60% locally manufactured health products and 40% imported, which will be a positive contribution to the reduction of substandard and falsified medicines and, of course, improve the health of our population. COVID-19 revealed gaps, and this helped make the case for focusing our attention on areas that had been neglected for years, including regulation and local manufacturing. 

 

In response, the Nigerian government has provided an intervention fund to improve the infrastructure of local manufacturers. NAFDAC has been very engaged in this process, in fact, we were championing local manufacturing since before the pandemic. The government’s intervention fund was made available to qualified companies to build internal capacity for pharmaceutical industry infrastructure.  NAFDAC acted as the ‘broker’ between the manufacturers and the Central Bank of Nigeria (CBN). Further, as part of this work to strengthen the health sector, the government, through CBN, also set up the Health Sector Research and Development (R&D) Intervention Scheme to make grants available for qualified research scientists from academic and manufacturing sectors. The focus is on translational research—which aims to build on scientific research to create new therapies, medical procedures, or diagnostics—of herbal medicines, medicines, and vaccines that could be developed into commercially viable products. I serve as Chair of this R&D Intervention Funding Scheme body of experts, which was set up by the CBN.

 

If Africa is going to rely on locally manufactured pharmaceutical products, what can be done to ensure regulatory quality?

 

Without stronger regulatory systems, the manufacturing system will not survive. From NAFDAC’s perspective, we are using globally recognized indices to determine whether our manufacturing companies are compliant or not. We inspected 165 companies over 6  months and categorized them into low risk, medium risk, or high-risk categories. The goal is to enable them to know how to go from high risk to medium risk, and from medium to low risk. As our part as a regulatory agency, NAFDAC is going through the World Health Organization’s (WHO) Global Benchmarking Tool to further strengthen its regulatory capacity. A regulatory authority that is weak cannot have industries that are strong. With the global benchmarking work, we are able to identify and address gaps, resulting in a stronger agency.

 

COVID-19 caught the world unprepared, including medicines regulatory agencies. What has your experience been like and how did NAFDAC overcome the challenges you faced?

 

Some of our challenges included the onslaught of applications for COVID-19 commodities and not having the proper guidelines to deal with this. Our agency has to work quickly to meet our regulatory obligations. We use good reliance practices in regulatory decision-making for medical products to expedite the evaluation and approval of these commodities. Reliance follows an initiative of the WHO to support regulators to make use of available resources and expertise to improve in-country vigilance, market surveillance, control activities, and oversight of local manufacturing and distribution.  This has worked favorably for the agency in granting registration and emergency use authorization. Approval time that usually took 120 days has been reduced to 10 to 30 working days. The agency also faced unproven claims for cures of COVID-19, primarily from herbal medicine practitioners and unscrupulous importers bringing in COVID-19 commodities without approval and under the pretext as a donation to the government or other private entities. Manufacturing companies also had to deal with disruptions in supplies of raw materials and finished products from India and China.   

 

And we’ve also had to contend with keeping regulatory processes going during a complete lockdown and working with fewer staff as the partial lockdown continues. Despite all this, guidance for some regulatory processes─COVID-related clinical trials and herbal medicines’ submissions─was implemented. Guidelines for manufacturing of personal protective equipment (PPEs) were also developed while weekly public safety education messages were carried out on national television, as part of the NAFDAC and its Your Health Program. NAFDAC also developed system-wide business continuity plans to handle emergencies for different regulatory processes as a continuation of our annual quality management system.  

 

Is NAFDAC ready to help roll out new vaccines and treatments for COVID-19? 

 

NAFDAC has definitely been engaged in discussions for  the roll-out of new vaccines and participated in various trainings and discussions with global and regional stakeholders, including the WHO, the African Vaccine Regulatory Forum (AVAREF), the International Coalition of Regulatory Authorities (ICMRA), and vaccine manufacturers. We are privileged to be one of two organizations in Africa that have been chosen to be part of the roll-out of vaccines with GS1 technology-driven traceability, which will use barcoding to track and trace vaccine distribution and support pharmacovigilance for monitoring adverse events following immunization. The MedSafety App, which the agency just acquired through WHO, will be used for this monitoring and reporting. Our agency also has a traceability desk, which was set up about a year ago, to work on this rollout.

 

So when a vaccine becomes available, NAFDAC, as a regulatory agency, will bring value in terms of licensing to ensure that quality, safety, and efficacy of the vaccines are based on international standards and approval, as well as acceptance by ICMRA and WHO. NAFDAC has been meeting with manufacturers to help them understand the licensing and EUA requirements, and our agency has just completed guidance on COVID-19 vaccines preparedness. It is my solid belief that we are ready in terms of vaccine introduction.  We will continue to do what it takes to ensure that whatever is coming is of high quality, is safe, and has the needed efficacy. 

 

Watch the recording of Seizing the moment: Providing faster access to quality medical products during COVID-19 and beyond, a conversation on novel approaches emerging from the COVID-19 response that can be effectively leveraged to respond to the pandemic while accelerating progress toward universal health coverage.