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

Frontiers in Medicine

article

Maja Pizevska¹  Jaspal Kaeda²  Enrico Fritsche²  Hisham Elazaly¹  Petra Reinke¹  Leila Amini¹ 

[1] Berlin Institute of Health at Charité — Universitätsmedizin Berlin, Berlin Institute of Health Center for Regenerative Therapies;Berlin Center for Advanced Therapies ,(BeCAT), Charité-Universitätsmedizin Berlin

关键词: regulatory affairs;    European Medicines Agency;    legislation;    regulatory science;    Paul-Ehrlich-Institute (PEI);    advanced therapy medicinal product (ATMP);    cell and gene therapies;   

DOI  :  10.3389/fmed.2022.757647

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 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.

【 授权许可】

CC BY