实施和监测高风险原药物风险最小化措施的实际考虑
Marion Mueller1, Joseph Peakin2, David J Lewis3,4
1Safety Risk Detection and Management, Novartis Pharma AG, Basel, Switzerland. Marion.mueller@novartis.com.
Pharmaceutical medicine
|August 18, 2023
概括
需要额外的风险最小化措施 (aRMMs) 的药物,如与怀孕预防计划一起使用的phthalimides,需要大量的资源. 早期规划和创新解决方案对于仿制药公司来说至关重要,以有效地管理这些复杂的要求.
科学领域:
- 药监和药物安全 药监和药物安全
- 制药政策和管理 制药政策和管理
背景情况:
- 社会对负担得起的药物的需求往往忽视了与额外的风险最小化措施 (aRMMs) 相关的大量成本.
- 一些药物产品,特别是那些具有原性潜力的药物,如胺,需要复杂和资源密集的监测和风险管理策略.
- 由于资源有限,仿制药制造商在管理这些苛刻的要求方面面临着独特的挑战.
研究的目的:
- 突出额外的风险最小化措施 (aRMM) 对药品生命周期管理的重大影响.
- 提供在aRMM的尽职调查,实施和监测期间的决策考虑,特别是对于仿制药.
- 在复杂风险管理的背景下,为积极的药监测提出创新和可持续的解决方案.
主要方法:
- 案例研究分析使用原性胺作为需要广泛的aRMMs的药物的例子.
- 通过控制分发系统 (CDS) 实施妊娠预防计划 (PPP) 的复杂性.
- 为卫生当局,公司和药监专业人员综合考虑.
主要成果:
- 实施aRMM,如PPP和CDS,是一项复杂,苛刻和昂贵的企业,影响商业化战略.
- 具有有限资源的通用营销许可证持有者需要具体的策略来管理这些义务.
- 有效的药物监督需要灵活和可持续的解决方案,这些解决方案超出了卫生当局的基本任务.
结论:
- 早期规划,知识共享和利用新技术对于有效管理aRMM至关重要.
- 仿制药公司可以从积极实施超出监管要求的措施中受益,以确保产品安全和生命周期可行性.
- 创新方法对于在日益复杂和资源限制的情况下保持高药监督标准至关重要.
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