Prof. Mojisola Christianah Adeyeye, Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), has stated that the country will soon begin manufacturing its own vaccines and that products approved by the agency will be easily traded globally.
At a press conference to commemorate her administration’s fourth anniversary, Adeyeye stated that the agency’s efforts are paving the way for Nigeria to manufacture its own vaccines once the World Health Organization (WHO) inspects the agency and declares it ML3 compliant.
The minimum WHO accreditation required to oversee vaccine production is ‘ML3’.
NAFDAC is working toward ML4, according to Adeyeye, which will allow products approved by NAFDAC to be easily traded across continents and globally.
If NAFDAC achieves WHO Maturity Level 4 (ML4) status, it will be able to perform Emergency Use Listing (EUL) with an emergency authorisation from the ML4 regulator, according to reliable sources. If the vaccine will be manufactured in a country whose regulatory agency is not ML4 but is considered “functional for vaccine oversight purposes,” it should be determined as soon as possible what level of authorisation (if any) will be required in the manufacturing country prior to EUL filing.
The foundation is being laid, according to Adeyeye, by the quality management system (QMS) and the WHO Global Benchmarking Tool (GBT), which will lead to a regulatory agency based on legacy building blocks.
Regulatory systems, she said, are critical in ensuring the quality, safety, and efficacy of medical products. Effective regulatory systems are an important part of health-care systems because they help to achieve desired public-health outcomes and foster innovation.
As mandated by World Health Assembly (WHA) Resolution 67.20 on Regulatory System Strengthening for Medical Products, GBT is the primary means by which the WHO objectively evaluates regulatory systems.
The press conference provided a unique opportunity for the public to reflect on the flurry of events, regulatory activities, challenges, opportunities, and accomplishments that have characterized NAFDAC’s journey to where it is today over the last four years.
“The current administration’s goal for the next four years is to protect public health, strengthen the industry, pursue customer-centric regulatory activities, play a key role in the growth of Micro, Small, and Medium Enterprises (MSMEs), enthrone top-notch QMS, and strive to achieve the WHO’s Level 3 GBT ranking,” says the statement.
To strengthen the agency, Adeyeye said it would take putting in place seven internationally defined building blocks based on WHO recommendations. “A quality system approach or template must be in place for a strong regulatory framework that prioritizes the customer.” As a result, we decided to implement an agency-wide quality management system (ISO 9001) that required all employees to undergo training (from February 2018 to June 2019) in self-auditing, standard operating procedures, proper documentation, transparency, and digitalization of her processes, among other things,” she explained.
She also stated that having a well-motivated staff who share the vision of making the agency strong is an important part of effective governance.
Staff training and capacity development have been given top priority under the current DG leadership, according to the agency. In the last four years, 3,600 employees have been trained or retrained. Similarly, employees are encouraged to enroll in academic programs to improve their job skills, as long as it does not interfere with their official responsibilities. Our employees are now more motivated, disciplined, and dedicated as a result of the transparent and quality-driven work environment that is expected of a regulatory agency.
“I believe that every state should have at least three vehicles for operation as an essential tool for the agency,” the DG continued. The agency’s most recent vehicles were purchased in 2014, before I took office. Because of the high rate of use, the majority of them are dilapidated. This is the type of vehicle that is always on the road. The directors, too, are without transportation. The contract for the 73 vehicles has been awarded, and the vehicles will be distributed among the directors for official use by December or January. The level of employee happiness has skyrocketed. There have been some exceptions that did not exist previously. We’re looking into the possibility of creating a new salary structure for our employees, as well as approaching the National Salaries and Wages Commission about the possibility of receiving additional benefits that we’ve never had before. For example, we’re considering how we can boost our hazard allowance, regulatory allowance, and other incentives to keep our employees motivated and productive.”
Adeyeye specifically mentioned a conducive environment for regulatory activities. She explained that while touring many state and zonal offices across the country, she witnessed a pitiful environment for dealing with customers, which has harmed staff productivity. As a result of NAFDAC’s prudent financial management, some Zonal/State Offices were budgeted for. She stated that plans are in the works to build five more.
From the 2021 budget, state offices will be established in Edo, Delta, Kano, Enugu, and Kaduna. She also mentioned that the NAHCO Ports Inspection Office in Ikeja, the Yaba Drug Laboratory expansion, and the Biologics/Vaccine Laboratory upgrade are all in the works.
In Nigeria, there was also a focus on local pharmaceutical manufacturing. The NAFDAC DG stated that the agency has prioritized local manufacturing of regulated products in order to ensure drug security in Nigeria and reduce imports from 70% to around 30% by 2025.
NAFDAC also stated that it is putting a greater emphasis on local herbal medicines by halting approval of imported herbal medicines with equivalence in Nigeria. This, according to Adeyeye, is to bring a renaissance to the country’s herbal medicines while also preventing falsification and counterfeiting.
“In order to achieve this goal, NAFDAC established the Herbal Medicine Product Committee in March 2019 and encouraged collaboration between herbal researchers and local practitioners.” This has resulted in the joint submission of research proposals for funding for clinical trials of products that have received NAFDAC listing approval so that they can receive full approval,” she explained.