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EU decision-making for marketing authorization of advanced therapy medicinal products: a case study

  • Published:2018-07 Issue:7 Volume:23 Page:1328-1333
  • ISSN:1359-6446
  • Container-title:Drug Discovery Today
  • language:en
  • Short-container-title:Drug Discovery Today

Author:

de Wilde Sofieke,Coppens Delphi G.M.,Hoekman Jarno,de Bruin Marie L.ORCID,Leufkens Hubert G.M.,Guchelaar Henk-Jan,Meij Pauline

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference31 articles.

1. Challenges with advanced therapy medicinal products and how to meet them;Schneider;Nat. Rev. Drug Discov.,2010

2. Regulation EC. 1394/2007 on advanced therapy medicinal products and amending Directive 2001/83. EC and Regulation (EC) No /726;EU;Off. J. EU,2004

3. Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive;Maciulaitis;Mol. Ther.,2012

4. Clinical development of gene- and cell-based therapies: overview of the European landscape;de Wilde;Mol. Ther.,2016

5. Advanced therapy medicinal products: current and future perspectives;Hanna;J. Mark. Access Health Policy,2016

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