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.

引用

页数：8

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