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Regulatory convergence and reliance
Scientific innovation is transforming the way medicines are discovered, developed, and evaluated, creating new opportunities to generate and analyze increasingly complex data and evidence. Regulatory science and regulatory systems need to evolve alongside these advances to ensure that scientific innovation can be effectively translated into innovative medicines for patients.
Against this backdrop, artificial <a href="https://myappsplus.com/nvidia-shares-drop-after-co-investigates-whether-ceo-was-target-of-a-foreign-intelligence-effort/” title=”Nvidia shares drop after co. investigates whether CEO was 'target of a foreign intelligence effort'”>intelligence offers opportunities to strengthen regulatory capacity, make more effective use of complex data and evidence, and support more efficient regulatory processes. For the innovative pharmaceutical industry, it is important that the frameworks that support the responsible and ethical use of these technologies keep pace with innovation while maintaining the rigour, trust, and confidence that underpin regulatory decision-making.
As national regulatory authorities increasingly explore AI-enabled approaches, greater alignment around principles, terminology, and strategies can help avoid regulatory fragmentation, facilitate shared learning and capacity building, and support more efficient global development and regulatory pathways.
Regulatory authorities are considering its use in areas such as internal operations, regulatory documentation, medicinal product review, and scientific assessment, inspections, and other regulatory procedures, with the potential to support regulatory activities and inform regulatory decisions.
This paper presents reflections from the innovative pharmaceutical industry on the use of AI by regulatory authorities in carrying out regulatory activities related to medicinal products. Drawing on publicly available initiatives and emerging experience, it sets out key considerations and observations regarding the opportunities, challenges, and implementation considerations associated with such use, and aims to inform dialogue among regulators, industry, and other stakeholders.
