Preparing for the Next Pandemic — Expanding and Coordinating Global Regulatory Capacity

   This Perspective argues for expanded and coordinated global regulatory capacity to ensure equitable access to diagnostics, therapeutics, and vaccines during future public health emergencies. The authors highlight the concentration of regulatory authority in high-income countries and the limitations of the WHO’s Prequalification (PQ) and Emergency Use Listing (EUL) systems, which rely heavily on stringent regulatory authorities like the FDA and EMA. Drawing lessons from Covid-19, they propose three key measures: (1) integrating WHO-listed authorities into regional coordination hubs for dossier review; (2) enabling multilateral development banks to accept approvals from maturity level 4 regulators for procurement financing; and (3) embedding regulatory flexibility into global pandemic agreements to decentralize review and accelerate access. A WHO table of national regulatory maturity levels is included, showing disparities in capacity across countries. The authors advocate for a shift from centralized approval to regionally empowered, transparent, and flexible systems that prioritize public health over procurement bottlenecks.

   This Perspective argues for expanded and coordinated global regulatory capacity to ensure equitable access to diagnostics, therapeutics, and vaccines during future public health emergencies. The authors highlight the concentration of regulatory authority in high-income countries and the limitations of the WHO’s Prequalification (PQ) and Emergency Use Listing (EUL) systems, which rely heavily on stringent regulatory authorities like the FDA and EMA. Drawing lessons from Covid-19, they propose three key measures: (1) integrating WHO-listed authorities into regional coordination hubs for dossier review; (2) enabling multilateral development banks to accept approvals from maturity level 4 regulators for procurement financing; and (3) embedding regulatory flexibility into global pandemic agreements to decentralize review and accelerate access. A WHO table of national regulatory maturity levels is included, showing disparities in capacity across countries. The authors advocate for a shift from centralized approval to regionally empowered, transparent, and flexible systems that prioritize public health over procurement bottlenecks.