给予适当的考虑
1Institute for European and International Law, Vienna University of Economics and Business Vienna Austria.
European journal of health law
|April 9, 2024
概括
欧盟关于卫生技术评估 (HTAR) 条例引入了联合临床评估 (JCA). 本文阐明了成员国在国家卫生技术评估 (HTA) 中关于JCA结果的义务.
科学领域:
- 卫生经济学 卫生经济学
- 监管事务 监管事务
- 制药政策 制药政策
背景情况:
- 欧盟关于卫生技术评估 (HTAR) 条例在欧盟一级建立了卫生技术的联合临床评估 (JCA).
- 在进行国家卫生技术评估 (HTA) 时,会员国必须考虑JCA的结果并履行其他义务.
研究的目的:
- 澄清有关JCA结果的HTAR下成员国的义务.
- 确定JCA结果是否必须在国家HTA流程之外考虑.
- 定义符合"国家HTA"资格的流程和触发第13条义务的要求.
主要方法:
- 欧盟关于卫生技术评估 (HTAR) 条例的法律和监管分析.
- 解释有关联合临床评估 (JCA) 和国家卫生技术评估 (HTA) 的义务.
主要成果:
- 这篇文章详细介绍了各成员国在考虑JCA结果时所面临的具体义务.
- 它涉及这些义务的适用范围,包括超出正式国家HTA的流程.
结论:
- 欧盟成员国已经定义了在国家HTA框架内考虑JCA结果的职责.
- 解释"国家HTA"和第13条要求对于遵守HTAR至关重要.
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