Advanced Therapy Medicinal Products - a Multiple Challenge
نویسندگان
چکیده
منابع مشابه
Considerations on paediatric investigation plans for advanced therapy medicinal products
In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must therefore obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA). Because ATMPs are different from ‘conventional’ medicinal products, defining t...
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OBJECTIVE Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to...
متن کاملAdvanced therapy medicinal products: current and future perspectives
BACKGROUND Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health benefits, but also to substantially impact the pharmaceuticals budget. OBJECTIVE The aim of this study was to characterise the ATMPs in development and discuss future implicatio...
متن کاملAdvanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe
In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regu...
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Mesenchymal stromal cells (MSCs) have been established as promising candidate sources of universal donor cells for cell therapy due to their contributions to tissue and organ homeostasis, repair, and support by self-renewal and multidifferentiation, as well as by their anti-inflammatory, antiproliferative, immunomodulatory, trophic, and proangiogenic properties. Various diseases have been treat...
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ژورنال
عنوان ژورنال: Transfusion Medicine and Hemotherapy
سال: 2013
ISSN: 1660-3818,1660-3796
DOI: 10.1159/000357305