Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

被引：19
|
作者：
Pizevska, Maja [1 ]
Kaeda, Jaspal [2 ]
Fritsche, Enrico [2 ]
Elazaly, Hisham [1 ]
Reinke, Petra [1 ,2 ]
Amini, Leila [1 ,2 ]
机构：
[1] Charite Univ Med Berlin, Berlin Inst Hlth, Ctr Regenerat Therapies, Berlin, Germany
[2] Charite Univ Med Berlin, Berlin Ctr Adv Therapies BeCAT, Berlin, Germany
来源：
FRONTIERS IN MEDICINE | 2022年 / 9卷
基金：
欧盟地平线“2020”;
关键词：
regulatory affairs; European Medicines Agency; legislation; regulatory science; Paul-Ehrlich-Institute (PEI); advanced therapy medicinal product (ATMP); cell and gene therapies; REGULATORY PATHWAYS; GENE THERAPIES; CELL; CHALLENGES; INNOVATION; SCIENCE;
D O I：
10.3389/fmed.2022.757647
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-engineered therapies have demonstrated enormous therapeutic benefits. However, their development is complex to be managed efficiently within currently existing regulatory frameworks. Legislation and regulation requirements for ATMPs must strike a balance between the patient safety while promoting innovations to optimize exploitation of these novel therapeutics. This paradox highlights the importance of on-going dynamic dialogue between all stakeholders and regulatory science to facilitate the development of pragmatic ATMP regulatory guidelines.
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收藏
页数：8
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