一个词有什么意思? 定义"基因治疗药物"
Maren von Fritschen1, Ewa Janosz2, Constanze Blume3
1Moderna Netherlands, Claude Debussylaan 7, 1082 MC Amsterdam Zuid, the Netherlands.
Molecular therapy. Methods & clinical development
|November 6, 2024
概括
欧盟委员会的新立法扩大了基因疗法药品 (GTMP) 的定义,包括基因组编辑和核酸疗法. 这种包容性定义影响了基因干预的监管途径和科学分类.
科学领域:
- 药理学 药理学是指药理学的学科.
- 遗传学 遗传学 是一个
- 监管科学 监管科学
背景情况:
- 基因疗法药物 (GTMPs) 代表了医学上的重大进步.
- 准确的定义对于监管框架和科学理解至关重要.
- 欧盟委员会在2023年4月提出了新的制药立法.
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