Position paper
4 Mar 2026
Artificial intelligence in pharmaceutical manufacturing – navigating innovation and regulation
Artificial Intelligence (AI) and Machine Learning (ML) are rapidly transforming various sectors, and the pharmaceutical manufacturing industry is no exception. This paper explores how the pharmaceutical industry may use individual applications of AI in pharmaceutical manufacturing and control. It describes the evolving regulatory landscape and provides key considerations for national regulatory authorities (NRA) when reviewing...
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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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