Terms of Reference: Capacity of Other Key Regulatory Agencies Involved in the Malaria Health Commodity Value Chain in Nigeria
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.
This consultancy aims to assess the capacity of Nigeria's key regulatory agencies involved in the health commodity value chain (except NAFDAC) and recommend actionable strategies to strengthen their performance. Specifically, the assessment aims to map the institutional mandates and responsibilities of these agencies; assess their technical, financial, operational, and human resource capacity; identify bottlenecks in the registration, approval, research, and distribution processes for health commodities; evaluate inter-agency coordination, data management, and digital systems used in regulation; and propose evidence-based recommendations to strengthen regulatory systems and enable efficient service delivery.
The scope of work for this consultancy includes the following:
- Stakeholder Engagement - Identify and actively engage with other key regulatory institutions such as PCN, NIPRD, SON, the Federal Ministry of Health, and other relevant entities to ensure alignment, obtain input, and foster collaboration for regulatory system strengthening.
- Regulatory Framework Review - Conduct a comprehensive desk review of institutional mandates, standard operating procedures (SOPs), relevant laws and policies, and existing regulatory assessment reports to understand the current regulatory environment and identify areas for improvement.
- Systems and Resource Evaluation - Assess the internal structures, processes, and human and technical resources used for critical regulatory functions, including product registration and approval, facility licensing, inspection systems, health research oversight, and product distribution and supply chain monitoring.
- Assess the capacity of regulatory bodies to conduct effective pharmacovigilance, ensure post-market surveillance of medical products, and enforce robust quality assurance and control measures to protect public health.
- Readiness for Innovation and Scale-Up - ▪ Examine the regulatory system's readiness to adapt to new and emerging health technologies, digital health solutions (e.g., AI-driven tools and telemedicine platforms), and increased local manufacturing of pharmaceuticals and medical devices.
- International Collaboration and Harmonization - Explore existing and potential mechanisms for regulatory reliance, harmonization of standards, and collaboration with regional (e.g., African Medicines Agency) and global bodies (e.g., WHO) to improve efficiency, reduce duplication, and leverage international expertise.
- Conduct a detailed gap analysis to identify regulatory capacity constraints and propose a tailored capacity development roadmap, including workforce strengthening, technical assistance, digital tools, and policy reforms to support long-term system resilience.
Nigeria's regulatory environment for health commodities plays a critical role in ensuring the safety, efficacy, and availability of medical products across the country. However, fragmented mandates, limited institutional capacity, and slow regulatory processes hinder timely access to essential health commodities and innovations. Strengthening these systems is vital for achieving national health goals and aligning with global best practices. To address these challenges, PVAC seeks to engage a qualified consultant to conduct a comprehensive capacity assessment of key regulatory agencies involved in Nigeria's registration, production, research, and distribution of health commodities.
The assignment will adopt a mixed-methods and participatory approach, including:
Desk Review
- Conduct an in-depth analysis of relevant national policies, regulatory frameworks, institutional documents, and previous assessment reports.
- Include benchmarking against international and regional standards such as the WHO Global Benchmarking Tool and the African Union Model Law on Medical Products Regulation.
Key Informant Interviews (KIIs)
- Hold structured interviews with leadership and technical staff of key regulatory agencies, pharmaceutical manufacturers, researchers, and private sector stakeholders.
- Gain insights into operational realities, regulatory challenges, and opportunities for system strengthening.
Organizational Capacity Assessment Tool (OCAT)
- Utilize a customized OCAT framework to assess the institutional capacity of regulatory bodies.
- Evaluate dimensions such as governance, organizational structure, staffing and human resources, technology adoption, physical infrastructure, and quality of service delivery.
Validation Workshop
- Organize a participatory workshop with key stakeholders to present preliminary findings, gather feedback, and validate conclusions.
- Ensure consensus on priority capacity gaps and jointly refine the capacity development roadmap.
The expected outcomes include:
- A detailed capacity assessment report of the key regulatory agencies with strengths, weaknesses, and capacity gaps.
- A stakeholder map and institutional mandate alignment analysis.
- Recommendations for strengthening governance, systems, coordination, and resource mobilization.
- A strategic roadmap and costed capacity-building plan for improving regulatory functions across the value chain.
- Policy briefs and presentation slides for advocacy and dissemination.
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:
- At least 10 years of experience with national or regional regulatory systems, preferably in sub-Saharan Africa
- Deep understanding of the health commodity landscape and institutional capacity development
- Experience with product registration, quality assurance, and pharmacovigilance systems
- Demonstrated experience conducting organizational capacity assessments using qualitative and quantitative tools
- Strong facilitation and communication skills to engage multi-sector stakeholders
- Familiarity with national laws, policies, and international standards (e.g., WHO, AUDA-NEPAD, AMRH)
2 months -- May to June, 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
3. Financial Proposal -- including clear budget narratives.
All required documents should be sent to [email protected] on or before May 19th, 2025. Proposals sent after this date will not be considered.