Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective.
| Autor: | Pizevska M; Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany., Kaeda J; Berlin Center for Advanced Therapies (BeCAT), Charité-Universitätsmedizin Berlin, Berlin, Germany., Fritsche E; Berlin Center for Advanced Therapies (BeCAT), Charité-Universitätsmedizin Berlin, Berlin, Germany., Elazaly H; Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany., Reinke P; Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany.; Berlin Center for Advanced Therapies (BeCAT), Charité-Universitätsmedizin Berlin, Berlin, Germany., Amini L; Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany.; Berlin Center for Advanced Therapies (BeCAT), Charité-Universitätsmedizin Berlin, Berlin, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | Frontiers in medicine [Front Med (Lausanne)] 2022 Feb 03; Vol. 9, pp. 757647. Date of Electronic Publication: 2022 Feb 03 (Print Publication: 2022). |
| DOI: | 10.3389/fmed.2022.757647 |
| Abstrakt: | 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. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Pizevska, Kaeda, Fritsche, Elazaly, Reinke and Amini.) |
| Databáze: | MEDLINE |
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