Skerritt John H, Mayer Mark, Francer Jeffrey
Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, 3010, Australia.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Ther Innov Regul Sci. 2025 Jun 8. doi: 10.1007/s43441-025-00817-8.
There has been a significant growth in international regulatory information-sharing and work-sharing initiatives in recent years, leading to reductions in submission lag and regulatory review timeframes. However, regulatory approvals in some major countries can still lag by months or years after the first global approval, with impacts on availability of new medicines for patients. This review assesses the impact of current international collaborative initiatives and proposes some options for their advancement. It also explores the potential impact of other factors such as greater alignment and collaboration on facilitated pathways, Good Manufacturing Practice) GMP inspections on regulatory timeframes and makes suggestions for improvements of regulatory convergence, collaboration, reliance and administrative procedures. While international collaborative regulatory assessments are still relatively new, in the following years, we consider that these pathways will become even more routine and impactful, especially if they can be further adapted.
近年来，国际监管信息共享和工作共享举措显著增加，使得申报滞后时间和监管审查时限得以缩短。然而，一些主要国家的监管批准仍可能在首次全球批准后的数月或数年出现滞后，这对患者获得新药产生了影响。本综述评估了当前国际合作举措的影响，并提出了推进这些举措的一些选择。它还探讨了其他因素的潜在影响，例如在便利途径上加强协调与合作、药品生产质量管理规范（GMP）检查对监管时限的影响，并就改善监管趋同、合作、互认和行政程序提出了建议。虽然国际合作监管评估仍相对较新，但在未来几年，我们认为这些途径将变得更加常规且更具影响力，尤其是如果它们能够得到进一步调整的话。
