荷兰药物监管科学的演变:不仅仅是一个国家报告
Anna M G Pasmooij1,2,3, Peter G M Mol1,3,4, Jacob Cornelis Bot3,5,6
1Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
Clinical pharmacology and therapeutics
|April 29, 2024
概括
荷兰的药物监管科学通过利益相关者的合作勃发展,将研究纳入药物开发和政策中. 关键的举措和不断发展的欧洲立法已经大大推进了这一领域.
科学领域:
- 药物监管科学 药物监管科学
- 药物 研究 研究 研究 研究
- 临床药理学 临床药理学
- 卫生政策 卫生政策
- 欧盟立法 欧盟立法
背景情况:
- 荷兰的药物监管科学是一个动态的,协作性的国家和国际领域.
- 监管科学在药物研究,临床药理学,政策制定和监管中得到了成功的整合.
- 欧洲法律框架的演变,包括欧盟的孤儿药物和药物监管立法,推动了监管科学的进步.
研究的目的:
- 审查促进荷兰药物监管科学中利益相关方成功合作的因素.
- 分析监管科学在更广泛的药物开发和监管生态系统中的嵌入.
- 确定塑造监管科学研究议程的关键事件和影响.
主要方法:
- 审查荷兰药物监管科学的历史发展和关键举措.
- 分析欧洲立法变化对监管科学研究的影响.
- 检查临床药理学和多方利益相关者参与的作用.
主要成果:
- 确定了三个关键事件:TI Pharma Escher项目,荷兰药品评估委员会的催化作用,以及荷兰监管科学网络的建立.
- 欧洲的立法变化 (例如,欧盟孤儿药物,欧盟药物监督立法) 已显著影响了监管科学议程.
- 临床药理学在塑造关于药物批准证据要求的讨论中发挥了重要作用.
结论:
- 多种利益相关者 (学术界,监管机构,行业,患者组织) 之间的成功合作对于推进药物监管科学至关重要.
- 鉴于多方越来越多的兴趣,连接监管科学活动至关重要.
- 荷兰是将监管科学纳入综合药品生态系统的典范.
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