| Challenges with advanced therapy medicinal products and how to meet them. | |
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MedLine Citation:
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PMID: 20190786 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. They have therefore been subject to considerable interest and debate. Following the European regulation on ATMPs, a consolidated regulatory framework for these innovative medicines has recently been established. Central to this framework is the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA), comprising a multidisciplinary scientific expert committee, representing all EU member states and European Free Trade Association countries, as well as patient and medical associations. In this article, the CAT discusses some of the typical issues raised by developers of ATMPs, and highlights the opportunities for such companies and research groups to approach the EMA and the CAT as a regulatory advisor during development. |
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Authors:
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; ; Christian K Schneider; Paula Salmikangas; Bernd Jilma; Bruno Flamion; Lyubina Racheva Todorova; Anna Paphitou; Ivana Haunerova; Toivo Maimets; Jean-Hugues Trouvin; Egbert Flory; Asterios Tsiftsoglou; Bal?zs Sarkadi; Kolbeinn Gudmundsson; Maura O'Donovan; Giovanni Migliaccio; J?nis Anc?ns; Romaldas Maciulaitis; Jean-Louis Robert; Anthony Samuel; Johannes H Ovelg?nne; Marit Hystad; Andrzej Mariusz Fal; Beatriz Silva Lima; Anca Stela Moraru; Peter Turc?ni; Robert Zorec; Sol Ruiz; Lennart Akerblom; Gopalan Narayanan; Alastair Kent; Fabrizia Bignami; J George Dickson; Dietger Niederwieser; Mar?a-Angeles Figuerola-Santos; Ilona G Reischl; Claire Beuneu; Rosen Georgiev; Maria Vassiliou; Alena Pychova; Mette Clausen; Taina Methuen; Sophie Lucas; Martina Sch?ssler-Lenz; Vasilios Kokkas; Zsuzsanna Buz?s; Niall MacAleenan; Maria Cristina Galli; Aija Lin?; Jolanta Gulbinovic; Guy Berchem; Mariusz Fraczek; Margarida Menezes-Ferreira; Nela Vilceanu; Mikul?s Hrubisko; Petra Marinko; Marcos Tim?n; Wing Cheng; George Andrew Crosbie; Nick Meade; Michelino Lipucci di Paola; Thierry VandenDriessche; Per Ljungman; Lucia D'Apote; Olga Oliver-Diaz; Isabel B?ttel; Patrick Celis |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Nature reviews. Drug discovery Volume: 9 ISSN: 1474-1784 ISO Abbreviation: Nat Rev Drug Discov Publication Date: 2010 Mar |
Date Detail:
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Created Date: 2010-03-01 Completed Date: 2010-04-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101124171 Medline TA: Nat Rev Drug Discov Country: England |
Other Details:
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Languages: eng Pagination: 195-201 Citation Subset: IM |
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| MeSH Terms | |
Descriptor/Qualifier:
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European Union Gene Therapy / legislation & jurisprudence*, methods Government Regulation* Humans Stem Cell Transplantation / legislation & jurisprudence*, methods Tissue Engineering / legislation & jurisprudence* |
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