P109/P110: Evaluating a Continental Pilot for Medicines Listing in Africa: Lessons for Reliance and Efficiency as well as AMA Readiness
Poster Presenter
Alex Juma Ismail
PhD Student
University of Hertfordshire United Kingdom
Objectives
To evaluate the performance, feasibility, scalability, and system-level lessons learnt from Africa’s first continental procedure for evaluation and listing of human medicinal products, and to assess its implications for the design and within Africa reliance by the African Medicines Agency (AMA).
Method
A retrospective mixed-methods programme evaluation was conducted using document review, focus group discussions, surveys, process mapping, and quantitative analysis of assessment timelines and inspection outcomes from the AMRH continental listing pilot implemented between 2023 and 2025.
Results
The continental listing pilot assessed 24 applications and resulted in the listing of 12 medicinal products, including vaccines, biologicals, and generic medicines, with 10 products meeting the 210-day target timeline. The pilot mobilised a multinational pool of 74 assessors and 50 GMP inspectors drawn from across 17 African countries, demonstrating the feasibility of coordinated, continent-wide regulatory work-sharing. The deficiencies we observed align with patterns publicly reported by regulators like the EMA and USFDA.
Key enablers of performance included a defined end-to-end procedure, strong technical committee coordination, expert consensus during scientific deliberations and structured quality-assurance mechanisms. These enabled the generation of consolidated scientific opinions that National Regulatory Authorities (NRAs) used to accelerate national decision-making.
However, multiple system-level bottlenecks were identified. These included challenges in dossier access due to fragmented digital platforms, variable assessor and inspector readiness for complex products and complext sections of the CTD dossiers, communication gaps between continental and national levels and delays in GMP inspection logistics.
Translation of continental listings into national marketing authorisations varied widely. While some NRAs implemented reliance-based approaches with minimal additional review, others introduced parallel administrative steps, duplicate GMP verification or legal reviews resulting in delayed decisions. Surveys of regulators and stakeholders showed strong support for standardized procedures, harmonised reliance frameworks, interoperable digital systems, predictable financing, and clearer legal recognition of AMA outputs by participating NRAs.
The evaluation synthesised findings into a structured “Top Lessons and Recommendations Matrix” and developed a Learning & Development (L&D) Loop to institutionalise continuous improvement for future AMA operations.
Conclusion
The pilot’s success demonstrates the transformative potential of continental collaboration, proving that joint assessment and inspection are not only feasible but can significantly accelerate access to critical medicines while harmonising regulatory standards across Africa. For the African Medicines Agency (AMA) to scale this model sustainably and deliver lasting impact, a strategic, multi-faceted approach is essential. This requires moving beyond pilot frameworks to establish robust, system-level foundations.
Critical to this transition are targeted investments in digital infrastructure specifically a unified Regulatory Information Management System and in building a sustainable, skilled continental workforce. Equally vital is the harmonisation of national legal frameworks to enable seamless reliance on AMA outputs, preventing duplication and shortening approval timelines. Furthermore, the adoption of a predictable, mixed financing model is necessary to ensure operational continuity and expert retention.
Beyond these structural pillars, the institutionalisation of a structured learning and adaptation cycle within AMA's operations is paramount. By systematically capturing insights from ongoing work and translating them into improved guidance and processes, AMA can evolve into a high-reliability, learning-oriented organisation.
Therefore, the path forward involves concurrent action on two fronts: building foundational capacity and fostering a culture of continuous improvement. Key recommendations from this study are:
• Formalising reliance pathways based on AMA scientific decisions and outcomes
• Strengthening the capacity of assessors and inspector
• Embedding a learning loop
By implementing these, the AMA can embed its role as a catalyst for an efficient, equitable, and collaborative regulatory body in Africa. This model offers a powerful blueprint for resource-diverse regions worldwide seeking to enhance medicine regulation through strategic cooperation.
