The global clinical trial landscape is undergoing a profound transformation, driven by the increasing use of multiregional clinical trial designs, rapid advances in science and technology, and the growing need for coordinated regulatory approaches.

With the expansion of multiregional clinical research, the need for harmonized regulatory frameworks has become more urgent. Despite this shift, regulatory fragmentation—driven by country or region-specific requirements—continues to impede the efficient initiation and conduct of multiregional clinical trials. Such fragmentation delays trial start-up and can diminish the attractiveness of certain jurisdictions for clinical research.

Regulatory reliance, already a well-established practice in regulatory decision-making for marketing authorization and post-approval changes, offers a promising solution. By leveraging assessments conducted by trusted national regulatory authorities (NRAs), reliance mechanisms can reduce duplication, accelerate clinical trial approvals, and promote global collaboration.

Applying the principles of regulatory reliance to clinical trial review is both feasible and necessary to enhance efficiency, uphold the rights, safety, and well-being of trial participants, and foster harmonization.

This position paper outlines the scope of regulatory reliance in clinical trials, key principles for effective reliance in clinical trial reviews, and consideration for implementing reliance in these reviews.