Designing Medicines Reliance and Accelerated Access for Small Markets: A Comparative Institutional Analysis with Implications for New Zealand

This study employs a comparative institutional analysis combined with systematic documentary analysis to examine medicines regulatory pathways across eight jurisdictions (New Zealand, Australia, EU, UK, Canada, Singapore, Switzerland, Japan). It integrates three theoretical frameworks (Post-Normal Science, Principal-Agent Theory, Administrative Constitutionalism) to evaluate the trade-offs of reliance and fast-track mechanisms for small markets.