Terms of Reference: Development of a Digital System to Enhance NAFDAC’s Health Commodity Registration and Regulatory Processes

Nigeria faces a significant burden from both communicable and non-communicable diseases, which strains the healthcare system and hinders economic development. Despite ongoing efforts to address these challenges, the country remains heavily reliant on imports for essential health commodities. This dependency leads to high costs, supply chain vulnerabilities, and inconsistent availability of critical healthcare products. Strengthening local capacity and optimizing supply chain management is essential to improving the accessibility, affordability, and sustainability of healthcare products. This is key to advancing public health.

Market shaping strategies have proven successful in other health sectors by leveraging economies of scale, improving quality control, and enhancing distribution efficiency. Adopting this model for manufacturing and distributing essential health commodities could reduce costs, improve product consistency, and ensure more reliable supply chains. However, transitioning from an import-dependent system to one with a robust local production capacity and an efficient pooled procurement system is a complex process. It requires a comprehensive, multi-faceted approach that addresses manufacturing capabilities, quality assurance mechanisms, supply chain optimization, workforce capacity building, and supportive policy frameworks.

The Presidential Initiative for Unlocking Healthcare Value Chain (PVAC) and the National Malaria Elimination Programme (NMEP), with the support of the World Bank IMPACT, embarked on a project called "Enhancing Local Manufacturing and Supply Chain Management for Health Commodities and Supplies in Nigeria." This project aims to address these challenges through a phased approach that balances short-term and long-term objectives. The strategies for addressing these challenges will include developing and laying the groundwork for local manufacturing of malaria commodities (including ACTs, RDTs, APIs, and LLINs), enhancing production capacity, ensuring compliance with international quality standards, and fostering workforce development. At the same time, the project will focus on optimizing the pooled procurement of imported malaria commodities to improve cost-effectiveness and distribution efficiency. Over the medium to long term, these interventions will strengthen the entire health commodities value chain, create opportunities for economic growth, and support Nigeria's self-sufficiency in critical healthcare products. This comprehensive approach seeks to improve Nigeria's healthcare supply systems' efficiency and resilience while unlocking new economic opportunities within the country's health sector. The project duration is 1 year.

The objective of this consultancy is to design and implement a digital system that streamlines NAFDAC’s health commodity registration process. This initiative aims to reduce approval timelines, increase the throughput of applications, and enhance transparency, traceability, and efficiency in regulatory activities through the use of digital tools. Additionally, the system will integrate functionalities for post-market surveillance, pharmacovigilance, and clinical trial oversight into a unified platform. The consultancy will also ensure that the digital systems are aligned with international best practices and standards, including those set by WHO, ISO, and ICH.

The consultant/consulting firm is expected to:

1. Assess Current Digital Infrastructure

   • Review NAFDAC’s current technology systems, approval workflows, and data management practices.
   • Identify bottlenecks and opportunities for automation in regulatory processes.

2. System Design and Development

   Design a modular digital platform that supports at least one identified bottle-neck area and ensures:

   • Adherence to NAFDAC standards and guidelines
   • Application intake and tracking
   • Application documentation review.
   • Real-time dashboards for regulatory performance
   • Demonstrated improvement in application completion time.

3. Interoperability and Standards Alignment

   • Ensure system compliance with WHO, ISO and other applicable standards for similar systems to ensure digital health regulation compliance.
   • Integrate with existing NAFDAC systems and or ensure NAFDAC’s capacity to oversee and administer the system.

4. Pilot Implementation and Feedback

   • Develop user manuals and SOPs
   • Pilot the system within a selected department/unit.
   • Collect user feedback and refine functionalities.

Nigeria’s push toward local manufacturing of malaria health commodities requires a modernized regulatory system to handle increased product registrations, ensure quality, and align with international standards. NAFDAC’s current manual processes slow approvals and limit effective oversight. To address this, PVAC is seeking a qualified consultant to design and implement a digital system that streamlines NAFDAC’s registration process, integrates post-market surveillance and clinical trial management, and builds staff capacity. This initiative will enhance regulatory efficiency, support local manufacturing, and improve access to quality-assured health commodities.

1. Stakeholder Consultations

   • Engage NAFDAC staff and partners through structured interviews and discussions.
   • Identify system requirements based on real user needs and regulatory workflows.

2. Agile Development Process

   • Use iterative development cycles with regular user testing and feedback.
   • Collaborate closely with stakeholders to ensure system relevance and usability.

3. Co-development and Standards Integration

   • Collaborate with NAFDAC to co-develop the digital system ensuring it meets regulatory and operational requirements.
   • Integrate NAFDAC and other applicable national standards to promote compliance, data consistency, and interoperability.

4. Monitoring and Evaluation

   • Establish KPIs to track system performance and application throughput the project life cycle.
   • Use analytics to monitor usage, identify gaps, and inform improvement

The expected outcomes include:

• Inception report detailing findings from the system needs assessment.
• System architecture blueprint and development roadmap.
• Functional digital registration and regulatory platform (pilot-ready).
• User training sessions and SOPs/manuals.
• Report of pilot testing with clear metrics demonstrating potential gains from the technology
• Road map of next steps to scale up use.

The selection process will follow a Limited Consultant Qualification-Based Method (LCQBM). Under this approach, interested consultants/consulting firms will submit proposals in response to the Terms of Reference (TOR) issued by PVAC. As part of the evaluation, consultants/consulting firms must demonstrate their relevant experience and qualifications in managing similar projects. Only the most qualified consultants or firms with proven expertise in project management, monitoring & evaluation, and health supply chain optimization will be shortlisted and considered for final selection.

The required expertise for this scope of work includes:

• Proven experience in health tech systems design, especially for regulatory bodies.
• Expertise in software development, data security, and user experience design.
• Experience working with African regulatory agencies (preferably NAFDAC or similar).
• Familiarity with international regulatory standards (WHO, ICH, ISO).
• Strong background in implementing digital solutions for pharmacovigilance and clinical trial oversight.
• Demonstrated ability to manage multi-stakeholder projects with government partners.
• Experience developing and deploying end-to-end regulatory platforms, including modules for product registration, documentation tracking, and reporting.
• Ability to design systems that integrate with national health information infrastructure and regional regulatory frameworks (e.g., ECOWAS).
• Proven capacity to conduct stakeholder consultations and translate regulatory workflows into effective digital tools.
• Familiarity with agile development methodologies and iterative system rollouts in low- and middle-income countries.
• Track record of ensuring compliance with data protection and cybersecurity regulations in digital health projects.

4 months -- May to August, 2025

Interested organizations are expected to submit the following documents:

1. Technical Proposal: The technical proposal should include:

• A clear methodology that demonstrates expertise in managing this project.
• A track record and experience in implementing similar projects
• At least 3 references from similar projects

2. A valid CAC certificate (or equivalent)

3. Financial Proposal -- including clear budget narratives.

All required documents should be sent to [email protected] on or before May 19^th, 2025. Proposals sent after this date will not be considered.