Terms of Reference: Harmonization of Regulatory Standards for Local Manufacturing of Malaria Commodities 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.

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 develop a harmonized regulatory framework for the local manufacturing of malaria commodities in Nigeria, ensuring quality, efficiency, and alignment with international standards. These malaria commodities include but are not limited to ACTs, RDTs, LLINS, vaccines, and other malaria commodities. Specifically, the consultancy will assess existing regulatory standards and frameworks guiding local production and identify gaps, overlaps, and inconsistencies among regulatory agencies such as NAFDAC, the Pharmacy Council of Nigeria (PCN), the Standards Organisation of Nigeria (SON), the National Institute for Pharmaceutical Research and Development (NIPRD), and the Federal Ministry of Health (FMoH). It will also propose a unified regulatory model aligned with global best practices, including those of the WHO, AUDA-NEPAD, and ECOWAS. Furthermore, the consultancy will develop a detailed implementation roadmap outlining institutional roles, timelines, capacity needs, and monitoring frameworks.

The consultant/consulting firm is expected to:

• Map all regulatory bodies and their roles

  • Identify key regulatory agencies (e.g., NAFDAC, PCN, SON, FMoH, NIPRD).
  • Define their authority, functions, and overlaps.
  • Document coordination mechanisms and institutional capacity.

• Review and analysis of national and regional regulatory frameworks

  • Assess national and regional frameworks (e.g., RMVC), policies, and guidelines on GMP, product registration, lab testing, and licensing.
  • Evaluate the effectiveness and efficiency of current procedures and identify bottlenecks.

• Conduct stakeholder consultations through key informant interviews

  • Conduct key informant interviews with regulatory agencies, manufacturing companies, and policymakers.
  • Gather feedback on regulatory challenges, constraints, and opportunities for improvement.
  • Facilitate multi-stakeholder dialogues for consensus-building.

• Benchmark against international and regional best practices

  • Compare Nigeria's practices with WHO PQ, AMRH, EU GMP, and USFDA.
  • Identify adaptable models and frameworks, highlighting success stories from peers.

• Develop a document with harmonized regulatory standards

  • Compile a document with harmonized regulatory standards, coordinated processes, and clear institutional roles.
  • Propose both short-term solutions and long-term structural reforms.

• Draft an implementation roadmap and policy recommendations

  • Outline actionable steps, timelines, responsible institutions, resources, and risk mitigation strategies.
  • Provide policy recommendations for regulatory reform and enforcement capacity.

• Organize a one-day validation workshop

  • Present findings, standards, and the implementation roadmap to stakeholders.
  • Solicit feedback, validate assumptions, and refine recommendations.
  • Strengthen buy-in and collective commitment to reform.

Nigeria's local health commodity manufacturing sector faces significant challenges, including regulatory inconsistencies, fragmented standards, and barriers to market access, which hinder the growth and competitiveness of local manufacturers. These issues result in inefficiencies, delays in product approvals, and increased costs, limiting the ability to meet domestic and regional demand for quality-assured health products. To address these challenges, PVAC seeks a consultant to develop a comprehensive framework for harmonizing regulatory standards, streamlining processes, eliminating duplication, and enhancing locally manufactured malaria commodities' overall quality and affordability.

The assignment will adopt a mixed-methods and participatory approach, including:

• Document Review:

  • Analyze existing regulatory policies, laws, and frameworks in the healthcare and pharmaceutical sectors.
  • Identify gaps, strengths, and opportunities for alignment with current needs and best practices.
  • Review past assessments, compliance records, and historical documents to understand regulatory evolution.

• Key Informant Interviews (KIIs):

  • Conduct in-depth interviews with regulatory agencies (e.g., NAFDAC), manufacturers, and policymakers.
  • Explore challenges in implementation, enforcement, and potential areas for improvement.
  • Understand institutional capacity gaps and barriers to effective regulation.

• Comparative Analysis:

  • Benchmark Nigeria's regulatory practices against regional and international standards.
  • Identify global best practices and assess how similar countries have addressed regulatory challenges.
  • Use case studies and literature to inform recommendations for improvement.

• Consensus Building:

  • Convene technical workshops and validation meetings with stakeholders to co-develop the harmonized framework.
  • Use evidence from KIIs, FGDs, and comparative analysis to refine proposals.
  • Ensure the framework reflects stakeholder input and promotes sustainable, effective regulation.

The expected outcomes include:

• Inception report outlining methodology, work plan, and timelines.
• Draft harmonized regulatory framework for health commodity manufacturing.
• Implementation roadmap (with indicators, responsibilities, timeline).
• Presentation of findings at a validation workshop.
• Finalized harmonized regulatory framework.

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 in health product regulation, pharmaceutical policy, or regulatory harmonization.
• Strong knowledge of the Nigerian regulatory context and international regulatory frameworks.
• Experience with legislative review and drafting of regulatory frameworks.
• Familiarity with the AU Model Law on Medical Products and Nigeria's regulatory institutions.
• Extensive experience in local pharmaceutical manufacturing, GMP compliance, and quality management systems.
• Experience in assessing regulatory cost implications and supply chain impact.
• Proven experience in convening multi-stakeholder policy dialogues and managing participatory processes.

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 (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.