Presentation (CTI)

OBJECTIVES: Regulatory systems are increasingly required to balance rapid access to innovation with financial sustainability and equitable support for emerging companies. This study presents a comparative landscape of fee structures, small and medium-sized enterprise (SME) incentives and performance frameworks across major global regulators, assessing how these elements contribute to regulatory evolution and sustainable health systems.
METHODS: We conducted a structured policy and benchmarking review of six regulators (FDA, EMA, MHRA, Swissmedic, Health Canada and TGA), drawing on fee schedules, service models and stakeholder insights from primary research. Analysis focused on three dimensions: (1) funding models (fee vs public financing), (2) SME support mechanisms, and (3) performance accountability frameworks, benchmarked against proposed reform timelines and funding mechanisms.
RESULTS: Fee-funded models dominate, with wide variation in magnitude and structure. SME incentives are widely embedded but heterogeneous: the EMA offers the most comprehensive relief (up to 90-100% fee reductions plus a dedicated SME Office), the FDA and Health Canada provide small-business waivers, reductions and deferrals, the TGA pairs orphan exemptions with advisory support, and Swissmedic offers only limited, case-by-case relief. On performance, most regulators commit to timeline-based standards without financial consequence for underperformance: the FDA links user fees to PDUFA review goals, the EMA, MHRA, Swissmedic and TGA operate statutory clocks, and Health Canada applies cost-recovery service standards with ‘stop-the-clock’ reporting.
CONCLUSIONS: The global regulatory landscape evolves towards blended models integrating economic sustainability, predictability and targeted innovation support. As national life-sciences strategies increasingly task regulators with optimising time to patient access as a lever for investment and growth, the operative mandate is shifting from raw speed to reliable speed: predictable, guaranteed timelines rather than best-effort velocity. Performance-linked frameworks operationalise this mandate, aligning economic incentives with public-service delivery; adoption may strengthen competitiveness for life-sciences investment while improving system-wide resource allocation and access timelines.