Strengthening Good Manufacturing Practice (GMP) Capacity Building to Improve Access to Cancer Medicines in Uganda: Gaps and Opportunities

PURPOSE Limited access to quality-assured cancer medicines remains a major challenge in Uganda, where over 90% of oncology medicines are imported, resulting in high costs and supply vulnerabilities. This assessment aimed at identifying systemic gaps and actionable opportunities for strengthening Good Manufacturing Practice (GMP) capacity to support local production of oncology medicines. METHODS A national multi-stakeholder needs assessment was conducted in Uganda between February and June 2025 across six purposively selected pharmaceutical manufacturers and key regulatory institutions. Data were collected through semi-structured interviews with quality assurance personnel, production managers, pharmacists, and regulators. The assessment focused on GMP compliance capacity, training systems, infrastructure readiness, and preparedness for technology transfer. Thematic analysis was performed using AI-assisted coding with manual validation. RESULTS The assessment revealed major barriers to GMP compliances including limited access to hands-on GMP training, infrastructure gaps, financial constraints, and weak quality management and documentation systems. Regulatory misalignment and low readiness for technology transfer were also noted, alongside organisational and behavioural barriers to sustained compliance. Readiness for local production varied, with some facilities reporting advanced GMP maturity, including WHO-prequalification (17%), while majority (83%) remain at early compliance stages. One manufacturer was ready to initiate local production of hydroxyurea, a high-demand medicine for heamato-oncology diseases, presenting a tangible opportunity to improved access. Despite these constraints, strong national commitment, emerging manufacturing capacity, and a growing public-private collaboration were evident. Stakeholders prioritized applied and context-specific stepwise GMP training, to enable facilities to progressively advance from basic compliance (eg, documentation and hygiene systems) to more complex requirements such as validation, HVAC control, supplier qualification and full quality management systems. There was strong demand for certification-based, in-person training and Training-of-Trainers models to support scalable and sustainable capacity development. CONCLUSION Improving access to quality cancer medicines in Uganda requires coordinated interventions across the pharmaceutical value chain. This assessment demonstrates that targeted GMP capacity strengthening, supported by multi-stakeholder partnerships, offers a practical and scalable pathway to advance local manufacturing at the national level. As a high-impact and transferable model, GMP capacity building can strengthen health systems and improve sustainable access to oncology medicines in low-resource settings.