Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States

Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States

Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for t...

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Bibliographic Details
Main Authors: Carolina Iglesias-Lopez, Antonia Agustí, Mercè Obach, Antonio Vallano
Format: Article
Language:English
Published: Frontiers Media S.A. 2019-08-01
Series:Frontiers in Pharmacology
Subjects:
genetic therapy
tissue engineering
cell- and tissue-based therapy
biological products
biological therapy
legislation and jurisprudence
Online Access:https://www.frontiersin.org/article/10.3389/fphar.2019.00921/full

Internet

https://www.frontiersin.org/article/10.3389/fphar.2019.00921/full

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