Reflection on the past seven years has brought into focus the many accomplishments that have been achieved in NAFDAC and so many others to be attained. This realization has sharpened my focus on how to strategically work towards continued strengthening of the regulatory system as a needed path toward safeguarding the health of the nation. In this bid, NAFDAC will continue to unlock the value chain through strengthening the industry with focus on access to quality regulated products.
Strengthening the regulatory system begins with our first Strategic Pillar – strong governance and leadership ensuring the workforce stays highly motivated and disciplined through. Our greatest need is adequate staff for all our regulatory activities at the headquarters, Lagos and all NAFDAC formations. We will engage volunteers while waiting for the statutory approval to satisfy the WHO Global Benchmarking requirements. For the new year, the staff renumeration will be given adequate attention. In terms of our infrastructure, the plan includes completing the building of ten state/zonal offices and laboratories including the Vaccines, Biologics and Medical Devices Laboratory in Oshodi. To support our expanding activities and MSMEs, tools such as vehicles, computers, needed laboratory equipment will be procured. As part of reducing the cost of energy needed for our facilities, solar panels will be built into existing selected facilities.
Training is premium for our staff; therefore, more focus will be paid to staff in the 36 states to increase the competence of the officers in areas such as Regulatory Inspection, Post-marketing Surveillance for all our regulated products, Safety Monitoring and Clinical Trial and Bioequivalence Inspection, Customer Service, NAPAMS V3, etc.
Using the training App, Directorates will be able to record the trainings in real time. There will be monthly Directorate-led seminars on critical topics that will include invitation of our strategic partners such as Pharmacy Council of Nigeria, Nigeria Customs Service, NDLEA, and ONSA.
Communication is very important to NAFDAC; publicity will focus more on issues such as mitigation of substandard and falsified medicines, unwholesome foods and one-health approach to preventing antimicrobial resistance. NAFDAC will hold joint sensitization with respective sister agencies and health partners via different media – print, radio, TV to ensure the public is adequately informed on regulated products and how to use them to improve healthy living.
NAFDAC ‘s second Strategic Pillar is Institutionalization of Best Practices; we plan to close any gap to maintain our ML3, and work toward achieving WHO Listed Authority Status (WLA) and ML4. This is to ensure that our regulated medical products are of quality, safe and efficacious. As part of our pathway to ICH membership, we plan to demonstrate implementation of ICH E6(R3) and ICH M13. We will be targeting attainment of Pharmaceutical Inspection Cooperation Scheme (PIC/S) certification to strengthen our Regulatory Inspection. The Agency’s use of Codex Alimentarius will remain strong to ensure that our foods are of quality, safe and tradeable. The Food Safety and Applied Nutrition Directorate will enhance the training of officers in ISO 22,000 and HACCP for improved competence. The Breastmilk Substitute (BMS) Code monitoring will continue with expansion of training to more states in the federation.
Safety and Quality of Regulated Products is NAFDAC’s Third Pillar and 2025 will be Maternal, Newborn and Child Health & Nutrition Year!! The focus is to prevent postpartum haemorrhage and maternal deaths, drastically reduce child morbidity.
This will be achieved by ensuring the quality, safety and efficacy of maternal health products such as Oxytocin, tranexamic acid, carbetocin and falsification and substandard products are re minimized to less than 5%. Similarly, great emphasis will be placed on paediatric antimalarials and antibiotics. Manufacturers will be incentivised to develop paediatric medicines and handheld toward achieving WHO Prequalification. Surveys will be conducted to follow up on quality of the medicines in the various markets. Similarly, Foods for malnourished children – ready to use therapeutic food (RUTF) will be adequately regulated while the new soybean-based-RUTF is supported through regulatory inspection and testing to ensure quality.
Regulation of global Listing involving foods will be heightened for public health protection. Cluster Registration of global listed products will be introduced while post-marketing inspection will be improved and monitored to ensure transparency and integrity of inspection reports. Products on global listing must come from countries with strong regulatory systems to ensure safety of the consumers. This will need a lot of stakeholder engagement.
The agency will increase the attention for our herbal medicines by seeking grants for clinical trials of already listed products. Collaborations with Nigerian Natural Medicine Development Agency (NNMDA) is being initiated. In the next three years, categories of listed products that will be considered include medicines for malaria, sickle cell, urinary tract infection, diabetes, Hypertension, arthritis, Immune boosting, skin infections. Other activities with NNMDA include Development of Nigerian Herbal Pharmacopoeia, development of Digital database of Nigerian Traditional Medicine and development of Nigeria Traditional Medicine FORMULARY.
Cosmetics will be given prime attention by de-aggregating the products from global listing. More training of stakeholders will take place every quarter to ensure understanding of cosmetics and impact on health. A study of cosmetics made in Nigeria will be done and compared to imported products to know if there is a need to put some imported cosmetics under NAFDAC Ceiling while local manufacturing is encouraged.
Monitoring of the Supply Chain: The aims behind this strategic plan are to make regulated products moving within the country visible, prevent diversion, infiltration of the supply chain and prevention of substandard and falsified commodities, thus ensuring the public health is protected. NAFDAC started Good Distribution and Storage Practice (GDSP) inspection in 2021 due to the pandemic that didn’t allow for physical inspection. Earlier in 2020, the agency introduced GS1-driven technology to monitoring of COVID-19 pandemic vaccines and became the first agency to serialize vaccines that came without barcoding to be consistent with vaccines that were received with barcodes. Since then, we have extended the monitoring of supply chain to non-Covid 19 vaccines, antimalarials, antiretrovirals and anti-tuberculosis medicines, commodities used for the Global Fund. In 2024, NAFDAC extended further the GS1-driven supply chain monitoring to private companies using narcotics as a class of drug for the pilot.
In 2025, the Agency will extend this monitoring to MNCH&N products to underscore the importance of making this class of products visible and protected from diversion and infiltration with unwholesome products. Solution providers that have been trained by GSI company will be used and the data will be harnessed in the already established NAFDAC Traceability Information System.
In a similar vein, the Food Safety and Applied Nutrition Directorate has initiated discussions with GSI on use of track and trace technology to monitor the distribution of some high-risk foods such as MNCH&N commodities.
Efficient Financial Management: National Agency for Food and Drug Administration and Control wouldn’t be where she is now without good financial management plan. The Agency went from over 3.2 billion debt inherited by my administration to solvency within a year of assumption of duty. Within that year (2018) Ports Inspection Directorate was able to recover over 700 million naira of evaded payments. Since then, NAFDAC has continued to digitize its systems to make the financial process transparent. The Agency is now using SAP system to manage its finances but internally, continued digitization is saving NAFDAC money by further plugging the holes. Based on the immensity of our regulatory activities, money is needed to increase staff strength, provide tools such as vehicles, laboratory equipment, computers and conducive work environments for the staff and MSMEs in the states, headquarters and states.
Thank You
Prof. Mojisola Christianah Adeyeye FAS
Director General
