Title:
Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective
Author(s):
Pizevska, Maja; Kaeda, Jaspal; Fritsche, Enrico; Elazaly, Hisham; Reinke, Petra; Amini, Leila
Year of publication:
2022
Available Date:
2022-08-30T09:06:29Z
Abstract:
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.
Part of Identifier:
e-ISSN (online): 2296-858X
Keywords:
regulatory affairs
European Medicines Agency
legislation
regulatory science
Paul-Ehrlich-Institute (PEI)
advanced therapy medicinal product (ATMP)
cell and gene therapies
DDC-Classification:
610 Medizin und Gesundheit
Publication Type:
Wissenschaftlicher Artikel
DOI of the Original Publication:
PubMed ID of the Original Publication:
Journaltitle:
Frontiers in Medicine
Publisher:
Frontiers Media SA
Department/institution:
Charité - Universitätsmedizin Berlin