Terms of Reference: Institutional Capacity Assessment of NAFDAC

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 assess existing capacity gaps within the National Agency for Food and Drug Administration and Control (NAFDAC) and develop a comprehensive capacity development plan to enhance its ability to fulfil its regulatory mandate. This assignment involves identifying technical, institutional, and operational gaps and designing a prioritized strategy to address them. It also includes developing targeted training modules tailored to the identified needs to strengthen NAFDAC's regulatory performance in line with international best practices and standards.

The consultant/consulting firm is expected to provide the required technical support to assess and improve NAFDAC's capacity to provide world-class quality assurance support to all parties involved in pharmaceutical manufacturing. Specifically:

1. Review the capacity needs of NAFDAC, including:

   • Current approval processes and capacity
   • Quality control and quality assurance standards
   • Regulatory processes
   • Laboratory capabilities for quality assurance processes
   • Clinical trials oversight
   • Pharmacovigilance capabilities
   • Post-approval and market surveillance regulation capabilities
   • Use of technology to increase efficiency

2. Co-develop (with NAFDAC) a short and mid-term quality assurance and capacity development plan, highlighting the capacity required to support the regulation of local manufacture of malaria commodities – APIs, ACTs, RDTs, and LLINs. This plan must highlight strategies to:

   • Increase NAFDAC's quarterly approval capability
   • Increase the annual quota of applications per manufacturer
   • Create a priority approval track for locally manufactured commodities
   • Increase the number of malaria products (ACTs, RDTs, LLINs, and APIs) approved for market.
   • Increase NAFDAC's capability to manage clinical trials, especially those related to malaria commodities (ACTs, RDTs, LLINs, and APIs)
   • Build industry capacity to comply with NAFDAC requirements

3. Develop priority training modules to address critical capacity gaps identified by NAFDAC and the industry.

NAFDAC plays a vital role in regulating food, drugs, and other products to safeguard public health in Nigeria. However, capacity gaps, ranging from technical skills to institutional systems, have limited its ability to fully deliver on its mandate in line with international best practices. Strengthening NAFDAC's capacity is critical to improving regulatory performance, ensuring product safety, and increasing public and stakeholder confidence. To this end, the PVAC initiative seeks a qualified consultant's expertise to assess these gaps and develop a comprehensive capacity development plan, including priority training modules tailored to address identified needs.

The expected outcomes include:

1. Capacity assessment report
2. A finalized short and mid-term quality assurance and capacity development plan, highlighting the capacity required to support the regulation of local manufacture of malaria commodities
3. Priority training modules to improve regulatory and industry capacity.

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 ability to support regulatory agencies in developing robust monitoring and evaluation mechanisms for quality assurance and clinical research activities.
• Demonstrate expertise in aligning regulatory agency operations with international standards, such as those established by the International Council for Harmonisation (ICH) or the World Health Organization (WHO).
• Strong track record in fostering cross-sector collaboration between regulatory agencies, academic institutions, and pharmaceutical companies to strengthen clinical research capacity.
• Possess extensive experience in conducting regulatory audits and providing actionable recommendations for operational improvements.
• Familiarity with developing risk management frameworks to address regulatory and clinical research challenges in West Africa.
• Ability to deliver high-impact workshops and training sessions tailored to the specific needs of regulatory staff and industry stakeholders
• Proven success in facilitating knowledge sharing and best practices among regulatory agencies within the African context.

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

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.