Suppr超能文献

The need for increased clarity and transparency in the regulatory pathway for gene medicines in the European Union.

作者信息

Ylä-Herttuala Seppo

出版信息

Mol Ther. 2012 Mar;20(3):471-2. doi: 10.1038/mt.2012.14.

Abstract
摘要

相似文献

2
The European Medicines Agency's goals for regulatory science to 2025.
Nat Rev Drug Discov. 2019 Jun;18(6):403-404. doi: 10.1038/d41573-019-00071-2.
4
Twenty Years of European Union Support to Gene Therapy and Gene Transfer.
Hum Gene Ther. 2017 Nov;28(11):951-953. doi: 10.1089/hum.2017.110. Epub 2017 Jun 29.
5
Challenges with advanced therapy medicinal products and how to meet them.
Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052.
6
Toward a proportionate regulatory framework for gene transfer: a patient group-led initiative.
Hum Gene Ther. 2011 Feb;22(2):126-34. doi: 10.1089/hum.2010.163. Epub 2011 Feb 2.
7
Regulatory evaluation of Glybera in Europe - two committees, one mission.
Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19.
8
Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.
Yale J Biol Med. 2017 Dec 19;90(4):683-693. eCollection 2017 Dec.
9
Agency defies advice and rejects gene therapy for third time.
Nat Biotechnol. 2012 Jun 7;30(6):474. doi: 10.1038/nbt0612-474b.

引用本文的文献

1
Navigating Gene Therapy Access: The Case of Bulgaria in the Context of the EU Regulatory Landscape.
Healthcare (Basel). 2024 Feb 11;12(4):458. doi: 10.3390/healthcare12040458.
2
Propelling Healthcare with Advanced Therapy Medicinal Products: A Policy Discussion.
Biomed Hub. 2020 Dec 3;5(3):130-152. doi: 10.1159/000511678. eCollection 2020 Sep-Dec.
3
Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption.
J Mark Access Health Policy. 2019 Apr 19;7(1):1600939. doi: 10.1080/20016689.2019.1600939. eCollection 2019.
4
Accelerating Patients' Access to Advanced Therapies in the EU.
Mol Ther Methods Clin Dev. 2017 Sep 22;7:15-19. doi: 10.1016/j.omtm.2017.08.005. eCollection 2017 Dec 15.
5
Regulatory evaluation of Glybera in Europe - two committees, one mission.
Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验