Reliance in decision-making offers a pathway for national regulatory authorities (NRAs) to consider evaluations conducted by other NRAs while maintaining accountability for their decisions.

By avoiding duplicative reviews and optimizing resource allocation, the use of regulatory reliance can lead to faster patient access to safe, effective, and high-quality medical products in a timely manner.

A key enabler of reliance-based scientific review and decision-making is the sharing of the assessment report prepared by a reference NRA. This report contains the reference NRA’s evaluation and benefit-risk scientific assessments of the product, including its analysis on the data on safety, efficacy, and quality. In essence, it outlines the rationale and evidence that supported the reference NRA’s regulatory decision. By leveraging this information, the relying NRA can build on the existing reference review and avoid duplicating efforts.

This paper examines the value of assessment reports in reliance-based regulatory frameworks and offers key recommendations to enhance their impact in a global regulatory environment.