动态监管评估:解开过程揭示了为欧洲的试点准备 - 一个EFPIA观点
Iain Todd1, Ruediger Faust2, Esteban Herrero-Martinez3
1GSK, Brentford, United Kingdom.
Clinical therapeutics
|September 13, 2023
概括
动态监管评估 (DRA) 为欧洲药品监管网络中分散的知识管理提供了解决方案. 使用离散数据包 (DDP) 试点DRA可以改善药物开发和授权.
科学领域:
- 监管科学 监管科学
- 制药发展 制药发展
- 欧洲卫生政策 欧洲卫生政策
背景情况:
- 欧洲经济区的药品监管网络涉及30个国家主管当局 (NCAs) 和欧洲药品管理局 (EMA).
- 目前,药物开发者和监管机构之间的知识管理是分散的,并且由于药物生命周期的参与不同,因此效率低下.
- 这种低效率可能会阻碍药物开发所必需的知识的不断积累.
研究的目的:
- 解开动态监管评估 (DRA) 概念,专注于离散数据包 (DDP).
- 展示DDP如何促进有前途药物的高效和可预测的数据发布.
- 倡导立即与欧洲监管机构试点DRA概念.
主要方法:
- 概念分析和评论,建立在之前的工作.
- 专注于DRA框架内的离散数据包 (DDP) 的机制.
- 探索如何代数据发布和评估可以增强监管流程.
主要成果:
- 通过使用DDP,DRA可以在监管网络中增加连接.
- 在商定的里程碑上反复释放和评估DDPs可以导致更有效的药物开发.
- 拟议的方法旨在促进新药的更快的授权.
结论:
- 动态监管评估 (DRA) 提出了一个可行的战略,以提高知识管理和监管效率.
- 离散数据包 (DDP) 对于实现持续的知识构建和可预测的数据流至关重要.
- 有一个明确的案例是与欧洲监管机构试点DRA概念,以实现其潜在的好处.
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