Regulatory reliance has emerged as a key strategy for strengthening regulatory systems by optimizing resources, reducing duplication, and accelerating access to high-quality medicines.

By leveraging the expertise and prior decisions of trusted national regulatory authorities (NRAs), reliance allows NRAs to focus their efforts on critical public health priorities while maintaining sovereignty over final regulatory decisions. Reliance-based approaches have been widely recognized in international frameworks, including WHO Good Reliance Practices (GRelP), as a means to enhance regulatory efficiency and promote collaboration among NRAs.

This allows for a more efficient allocation of resources, reduction in review timelines, and increased predictability for industry. Far from undermining sovereignty, reliance in fact strengthens regulatory decision-making by allowing NRAs to make science-based judgments while maintaining full authority over their processes. The decision to apply reliance, and how best to do so, rests entirely with the NRA.

This paper reflects upon industry experience with reliance-based processes and identifies critical success factors and best practices underpinning their effective implementation. By identifying practical solutions to common challenges and promoting effective reliance mechanisms, this paper aims to support the broader adoption of reliance as a sustainable approach to regulatory decision-making.