An Evaluation of Regulatory Pathways for Vaccine Development and Approval in Developed Versus Emerging Markets

Abstract

The aim of this thesis is to evaluate, compare, and synthesize vaccine regulatory pathways in selected developed versus emerging markets, with the overarching goal of identifying practical levers to shorten time-to-access without compromising the core pillars of quality, safety, and efficacy. This evaluation seeks to enhance both regulatory efficiency and global equity in vaccine availability.  This work conducted a comprehensive evaluation of vaccine regulatory pathways across developed and emerging markets, identifying both convergences and divergences in practices, processes, and capacities. Several key themes emerged: Convergence is growing but uneven: Regulatory systems worldwide increasingly share common features such as conditional approvals, rolling reviews, and reliance mechanisms. However, these mechanisms are more mature and consistently applied in developed markets, while adoption in LMICs remains uneven and resource-dependent. Reliance and rolling reviews as pivotal accelerators: Evidence from the COVID-19 pandemic demonstrates that reliance on WHO PQ/EUL and other global authorities, combined with rolling review models, significantly shortens time-to-market without compromising standards. CMC and pharmacovigilance capacity as persistent bottlenecks: Emerging markets often face resource limitations in conducting rigorous CMC reviews, GMP inspections, lot release testing, and maintaining robust PV systems. These gaps contribute to delays and uneven safety oversight. Policy options and sponsor strategies: Specific, feasible actions can be taken to compress regulatory timelines while preserving scientific rigor. These include embedding reliance frameworks in law, investing in regulatory infrastructure, pre-arranging lot release testing capacity, and leveraging digital traceability systems.