| The advanced therapy classification procedure : Overview of experience gained so far(1). | |
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MedLine Citation:
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PMID: 21698533 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs. This procedure gives companies the opportunity to verify whether or not the product they are developing can be considered an ATMP and can therefore benefit from the new regulatory pathway introduced in the European Union for these types of medicinal products. This procedure is optional, free of charge and may take place at any stage of the development of an ATMP in advance of applying for a marketing authorisation. In case of doubt, briefing meetings organised by the European Medicines Agency Innovation Task Force may help preparing for an ATMP classification and are a starting point for the interactions between the Agency and the developers of ATMPs. This article reviews the advantages of the classification procedure for both the developers of ATMPs and the European regulatory network. Since the introduction of this procedure and up to 10 November 2010, the Committee for Advanced Therapies (CAT) has finalised 38 applications for classification. |
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Authors:
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C Voltz-Girolt; P Celis; M Boucaumont; L D'Apote; M-H Pinheiro; M Papaluca-Amati |
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Publication Detail:
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Type: JOURNAL ARTICLE |
Journal Detail:
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Title: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Volume: 54 ISSN: 1437-1588 ISO Abbreviation: - Publication Date: 2011 Jul |
Date Detail:
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Created Date: 2011-6-23 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101181368 Medline TA: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Country: - |
Other Details:
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Languages: ENG Pagination: 811-815 Citation Subset: - |
Affiliation:
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Scientific Administrator- Biologicals, European Medicines Agency, 7 Westferry Circus, Canary Warf, E14 4 HB, London, UK, caroline.voltz@ema.europa.eu. |
Vernacular Title:
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Das Klassifizierungsverfahren neuartiger Therapien : Übersicht über bisherige Erfahrungen. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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