Search results for "Hospital Exemption authorisation"

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Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

2012

Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundation…

lcsh:Immunologic diseases. Allergymesenchymal stem/progenitor cellMesenchymal stem cells (MSC)ImmunologyReview ArticleCertificationBest interestsAgency (sociology)Hospital Exemption authorisationImmunology and AllergyMedicinemedia_common.cataloged_instanceProduct (category theory)European unionHospital Exemptionmedia_commonbusiness.industrynational competent authorityCommittee for Advanced TherapiesCell therapy medicinal product (CTMP)AuthorizationGuidance documentsCommittee for Advanced Therapies (CAT)Engineering managementNew product developmentadvanced therapy medicinal productlcsh:RC581-607businesscell therapy medicinal productAdvanced therapy medicinal product (ATMP)Frontiers in Immunology
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