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开拓未来:同时向全球监管机构提供首个数字生成的CMC审批后变更 (PAC) 档案
Marquerita Algorri1, Nina S Cauchon1, Kabir Ahluwalia1
1Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, Thousand Oaks, CA, 91320, USA.
Journal of pharmaceutical sciences
|February 6, 2026
概括
一个试点项目显著缩短了生物制药中批准后变化 (PAC) 的监管审批时间. 这一举措简化了化学,制造和控制 (CMC) 提交,加快了患者获得重要药物的机会.
科学领域:
- 制药科学 制药科学
- 监管事务 监管事务
- 过程改进 过程改进
背景情况:
- 生物制药公司面临的挑战是管理批准后的化学,制造和控制 (CMC) 变化,原因是耗时,行政繁重和特定区域的监管要求.
- 这些传统的过程往往会延迟关键的更新和改进,影响患者获得治疗的机会.
研究的目的:
- 描述一项专注于审批后变更 (PAC) 依赖/协作和数字创作的试点项目,以改善端到端提交流程.
- 通过创新的监管实践,证明在创作,审查和批准CMC变更方面可能节省时间.
主要方法:
- 启动和组织一个试点项目,涉及国家监管机构 (NRA) 和第三方协作平台.
- 利用自动化,基于云的协作,以及提交提交的共同核心CMC档案.
- 追踪国家监管机构的参与,并将批准时间与传统流程进行比较.
主要成果:
- 在37个目标NRA中,有27个NRA (73%) 参与,其中26个NRA使用了新的第三方协作平台.
- 85% (23/27) 的参与国家监管机构在9个月内获得批准.
- 这与通过传统提交流程进行可比变更所需的典型36个月相比,相当于大幅减少.
结论:
- 该试点在批准后的变更过程中证明了大量的时间节约和效率提升.
- 结果突出了人们对采用创新的监管实践和开发可扩展的依赖/协作途径的兴趣.
- 这些发现支持通过现代化的监管提交来加速患者获得关键疗法.
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