Prof. Adeyeye is a strong advocate for local manufacturing, supported by a robust regulatory system, as key to ensuring the availability of quality medicines.
In 2017, Professor Mojisola Christianah Adeyeye, an esteemed academic in Pharmaceutics, Manufacturing Science, and Drug Product Development, was appointed Director General of the National Agency for Food and Drug Administration and Control (NAFDAC) by former President Muhammadu Buhari.
At the time, the agency was in need of renewed energy to tackle the pressing issue of substandard foods and drugs in Nigeria. Upon assuming her role, Prof. Adeyeye introduced several initiatives aimed at safeguarding the health of Nigerians and foreigners in the country by preventing the circulation of counterfeit and substandard regulated products.
Her strategic approach led to remarkable achievements for NAFDAC, culminating in her reappointment in 2022 by the Buhari administration due to her exceptional performance. When the Tinubu administration assumed power in May 2023, a reorganization of agencies under the Ministry of Health and Social Welfare affected NAFDAC’s management and board, leading to the temporary stepping aside of its members.
However, following the reconstitution of the boards, Prof. Adeyeye was once again appointed to continue her outstanding work. Prof. Adeyeye expressed satisfaction with her accomplishments at NAFDAC, which resulted from the development and implementation of five key strategic plans: governance, strong leadership, the use of international best practices, combating substandard and counterfeit medicines, and ensuring financial accountability.
In a recent interview, she discussed the strategies she employed, which led to significant success for the agency. One of her key achievements was addressing NAFDAC’s financial challenges.
Professor Adeyeye led efforts to eliminate financial leakages by introducing cost-saving measures, such as adopting Zoom meetings to reduce unnecessary travel expenses. This initiative, introduced in March 2018, was ahead of its time and later became crucial during the pandemic. Additionally, she reduced the number of staff accompanying the Director General on international trips. Within a year, NAFDAC became solvent and was able to pay off a N3.2 billion debt. “We denied ourselves to avoid debt, and we have maintained this approach since 2017,” she recounted.
Strengthening NAFDAC’s regulatory framework was another priority. “A robust regulatory framework is essential for a strong regulatory agency,” she asserted. Shortly after her appointment, NAFDAC began implementing a quality management system, with agency-wide training lasting a year and a half to instill a customer-focused and agency-minded approach. Despite achieving ISO 9001 certification, training continues to this day. NAFDAC also prepared for the WHO Global Benchmarking Tool (GBT), which includes nine modules and 276 indicators. By March 2022, NAFDAC had addressed all 860 recommendations from 2018.
To combat falsified drugs, Professor Adeyeye implemented a multifaceted approach, including enhanced pre-shipment testing, laboratory improvements, and consistent reporting. “We prevented 140 products from entering the country through consistent laboratory reporting,” she noted. NAFDAC also developed its first-ever regulation for Good Distribution Practice (GDP) despite opposition from some stakeholders in the pharmaceutical sector.
Professor Adeyeye is a strong advocate for local manufacturing, supported by a robust regulatory system, as key to ensuring the availability of quality medicines. In line with this vision, NAFDAC launched the “Five + Five” initiative, which gives drug importers five years to begin local manufacturing. This initiative was spurred by a study showing that the top five imported products were already being manufactured locally. “Why should we import the same products?” she asked.
Vaccine production is another top priority for NAFDAC. Professor Adeyeye is pleased that “vaccine manufacturing is now within reach as NAFDAC has achieved maturity level 3. Without this, no country can produce vaccines. We reached level 3 in 2022 and are now working towards level 4.” Achieving this milestone involved meeting over 800 recommendations for both medicines and vaccines. “When I started, we were at -1. Now, we are moving to level 4. It requires immense effort, but we are committed,” she emphasized.
She has also called for public support in funding NAFDAC. “Regulatory agencies globally receive government funding, including user fees for inspections, laboratory testing, pharmacovigilance, and post-marketing surveillance. These fees should be untouchable, but we have yet to realize this in our country,” she said. Improved funding will enable NAFDAC to motivate its staff and deliver more effective regulation in this critical sector.
Regarding the misuse of prescription drugs, Professor Adeyeye urged the Ministry of Health and the Medical Association to develop and enforce a prescription policy. She recalled her volunteer days at the University of Florida in the early 1980s, where even as part of the workforce, she was unable to obtain a single paracetamol tablet without a prescription.
To raise public awareness, NAFDAC launched a bi-weekly television program titled “NAFDAC and Your Health,” aired on TVC and NTA. NAFDAC’s work under Professor Adeyeye’s innovative and dynamic leadership has also attracted global attention, particularly from the World Health Organization (WHO). This recognition culminated in the WHO granting Prequalification Status to NAFDAC’s Central Drug Control Laboratory (CDCL) in Yaba, Lagos State. This significant milestone underscores NAFDAC’s dedication to ensuring pharmaceutical product safety and quality. While the journey toward this achievement began in 2010, it was under Professor Adeyeye’s leadership, with support from the Federal Government, that the goal was finally realized.
The WHO Prequalification of the CDCL is a testament to NAFDAC’s unwavering commitment to meeting international standards of excellence in drug quality control and regulation. Notably, very few laboratories worldwide hold the apex status of WHO Prequalification.
Key benefits of the WHO Prequalification of NAFDAC CDCL include:
- Global Recognition: WHO Prequalification Status is a globally recognized badge of honor that attests to the CDCL’s competence in assuring the quality of pharmaceutical products. It places CDCL among an elite group of laboratories worldwide known for their excellence in drug analysis.
- Enhanced Pharmaceutical Quality: The prequalification of CDCL ensures that the quality, safety, and efficacy of medicines tested and certified by the laboratory meet the highest international standards. This directly translates to improved access to safe and effective medicines for the Nigerian populace.
- International Collaboration: CDCL’s new status opens doors to international collaboration with regulatory bodies, pharmaceutical manufacturers, and global health organizations. This collaboration will strengthen Nigeria’s pharmaceutical sector and contribute to advancing healthcare access in the region.
- Advancing Public Health: The CDCL plays a pivotal role in safeguarding public health by ensuring that substandard and counterfeit medicines do not reach the market. With WHO Prequalification, its impact in this regard will be even more profound, protecting Nigerian patients from potentially harmful products.
- Streamlined Regulatory Processes: WHO Prequalification can lead to streamlined regulatory processes, facilitating the faster approval of essential medicines in Nigeria and beyond.
- Enhanced Credibility: This prestigious status enhances NAFDAC’s credibility on the global stage and reinforces the trust of stakeholders, including pharmaceutical manufacturers, healthcare providers, and patients.
- Advancing Nigeria’s Healthcare System: The recognition of the NAFDAC CDCL by WHO is a significant milestone in strengthening Nigeria’s healthcare system, ensuring that Nigerians have access to high-quality healthcare products. For NAFDAC as a regulator, it further enhances our pedigree as we work towards Maturity Level 4, to become a World listed Authority. This achievement would not have been possible without the hard work, dedication, and unwavering commitment of the Honourable Minister of Health, NAFDAC management, CDCL staff, NAFDAC management, our esteemed partners such as WHO Nigeria Country Office, USP PQM+ Nigeria Country office and Global Fund.
