Background
The era of assumption-based drug development is giving way to model-informed drug development (MIDD), a shift from trial-and-error to strategic, evidence-driven innovation. Using computational modeling and simulation, MIDD predicts drug behavior, optimizes dosing, and reduces development risks before costly clinical trials. Despite its proven global impact, Africa’s fragmented regulatory systems and inconsistent guidelines limit its adoption, slowing innovation and patient access.
Methods
A review of global MIDD frameworks, including draft ICH M15 principles, identified adaptable components for African National Regulatory Authorities (NRAs).
Results
The proposed risk-based framework guides NRAs in model evaluation through five key factors: question, context, model influence, decision impact, and risk. Credibility is confirmed via verification, validation, and applicability. Two main tools enhance transparency and review efficiency:
- Model Analysis Plans (MAPs): Detailed workflows outlining assumptions, data, and methods
- Model Analysis Reports (MARs): Summaries presenting outcomes, deviations, and interpretations
This structure ensures consistent assessment across applications from dose selection to trial design and adapts to Africa’s diverse data realities. Key challenges include limited data, expertise shortages, variable regulatory readiness, and resource limits. Future focus areas are AI/ML integration
Conclusion
This framework embeds MIDD into African regulatory systems through harmonized, evidence-based standards. By improving evaluation, transparency, and collaboration, it shortens review times, strengthens regulatory confidence, and accelerates access to effective medicines—positioning Africa as a leader in global pharmaceutical innovation.
References
- Marshall S, et al. Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives. CPT Pharmacometrics Syst Pharmacol. 2019;82:87-96
- ICH M15: Principles and Practices of Model-Informed Drug Development. Draft Guideline. 2024
