全球行业调查关于审批后变更管理和依赖的使用
Andrew Deavin1, Aliyah Hossain2, Isabelle Colmagne-Poulard3
1GSK, 20 Avenue Fleming, 1300, Wavre, Belgium. andrew.x.deavin@gsk.com.
Therapeutic innovation & regulatory science
|August 23, 2024
概括
全球监管障碍对审批后变更 (PAC) 造成重大延误. 虽然人们对ICH Q12的认识越来越大,但实施仍然有限,影响了药物供应链和患者获得创新的机会.
科学领域:
- 药品监管事务 药品监管事务
- 全球药物制造标准全球药物制造标准
- 供应链管理 供应链管理
背景情况:
- 批准后的变化 (PAC) 对药物和疫苗创新和供应安全至关重要.
- 不同的国家PAC要求和漫长的审查时间表可能导致3-5年的延迟,危及短缺.
- 全球协调PAC流程对于有效的药物生命周期管理至关重要.
研究的目的:
- 在全球范围内评估ICH Q12指南和PAC程序的实施情况.
- 评估不同国家对PAC的依赖机制的采用情况.
- 确定简化PAC批准的挑战和机会,以确保持续供应和患者获取.
主要方法:
- 一项2023年进行的行业调查,涉及9名ICH成员和19名观察员.
- 评估ICH Q12实施,PAC分类,审查时间表和依赖机制.
- 将国家PAC分类和时间表与欧盟/世卫组织对四个CMC变更的参考标准进行比较.
主要成果:
- 有限的ICH Q12实施,特别是PACMP,既定条件和产品生命周期管理文件.
- 更多地采用基于风险的方法来对变异进行分类,但没有改善批准时间表.
- 与欧盟/世卫组织标准相比,PAC要求和时间表显著缺乏协调,特别是在ICH观察员中.
- 单方面依赖机制的新兴使用,以利用监管专业知识并减少审查重复.
结论:
- 尽管提高了意识和培训,但全球实施ICH Q12仍面临重大挑战.
- 不同的监管要求和有限的监管能力继续阻碍及时批准PAC.
- 赖兰斯机制为增强全球监管能力和简化审批提供了一个有希望的途径.
- 加快PAC批准对于患者获得创新和确保安全,有弹性的药物供应链至关重要.
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