Position paper
11 Dec 2025
The role of assessment reports in enabling regulatory reliance – perspectives from the pharmaceutical industry
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...
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Position paper
11 Dec 2025
Best practices for unilateral reliance for initial marketing authorization and post-approval changes
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....
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Position paper
25 Nov 2025
Considerations on the use of reliance in clinical trials review
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...
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