新方法方法论：欧盟监管视野

Nature Reviews Drug Discovery Pub Date : 2025-03-24 DOI:10.1038/d41573-025-00053-7

Mariana Edwards, Oriane Blanquie, Orla Moriarty, Sonja Beken, Falk Ehmann

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引用次数: 0

摘要

新方法方法（NAMs）有可能通过减少对动物试验的依赖，同时增加非临床数据与患者的相关性，逐步改变药物开发。然而，要让监管部门接受新兴市场名称，就需要加强合作、明确指导和持续的、基于科学的监管环境调整，以适应新兴创新。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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New approach methodologies: EU regulatory horizons

New approach methodologies (NAMs) have the potential to progressively transform medicines development by reducing reliance on animal testing while increasing the relevance of nonclinical data to patients. However, achieving regulatory acceptance of NAMs demands enhanced collaboration, clear guidance and continuous, science-based adaptation of the regulatory environment to accommodate emerging innovation.

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Nature Reviews Drug Discovery

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