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<p>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.</p>

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Strengthening the Use of International Collaborative Regulatory Assessments and Regulatory Alignment– Implications for Global Convergence

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年6月8日

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  • John H. Skerritt,
  • Mark Mayer,
  • Jeffrey Francer

摘要

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.