适用于母亲和新生儿健康的药物管理条例:一个景观评估
Amalia Alexe1, Anju Garg2, Birgit Kovacs3
1Novartis, Rue de La Tour de L`Ile 4, 1204, Geneva, Switzerland. amalia.alexe@novartis.com.
Therapeutic innovation & regulatory science
|December 17, 2023
概括
关于怀孕和母乳养期间药物安全性的证据有限. 协调全球法规和改善协作对于更好的患者结果和监管合规至关重要.
科学领域:
- 药物监督和监管科学 药物监督和监管科学
- 孕产妇和胎儿健康 孕产妇和胎儿健康
- 药品安全 药品安全
背景情况:
- 怀孕和母乳养期间药物安全性和疗效的证据不足,阻碍了患者和医疗保健专业人员的知情决策.
- 了解监管环境对于开发有效的工具和流程来研究这些人群中的药物使用至关重要.
研究的目的:
- 对有关怀孕和母乳养期间药物使用的法规,准则和指导进行景观评估.
- 确定卫生当局和其他组织的举措,以提高这些人群的药物安全性.
- 突出立法协调和利益相关方合作的必要性.
主要方法:
- 对全球多个地区 (美洲,欧洲,非洲,亚太地区) 的卫生当局的法规,准则和指导进行全面审查.
- 识别和总结来自各种利益相关者的相关举措,包括学术机构,行业和公私组织.
主要成果:
- 关于在怀孕和母乳养期间使用药物的全球药物监督立法正在发展,但在临床试验和营销后环境中缺乏协调.
- 全球许多国家和地区仍然存在重大监管差距.
- 尽管正在努力,但仍需要大量工作来改善药物安全环境.
结论:
- 协调全球立法和促进利益相关者加强合作对于解决现有的监管差距至关重要.
- 需要加大努力,以提高孕妇和哺乳期患者的药物安全性.
- 这些发现强调,需要采取统一的方法,在这些脆弱人群中对药物安全研究和监管进行统一的方法.
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