EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

Published 2019 View Full Article

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Title
EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation
Authors
Keywords
Marketing Authorisation, advanced therapy medicinal product, cell therapy, gene therapy, regulation, conditional approval, accelerated assessment, PRIME, RMAT designation, Sakigake designation
Journal
Molecular Therapy-Methods & Clinical Development
Volume 13, Issue -, Pages 205-232
Publisher
Elsevier BV
Online
2019-01-30
DOI
10.1016/j.omtm.2019.01.010

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