Hurdles in gene therapy regulatory approval: a retrospective analysis of European Marketing Authorization Applications

Author:

Carvalho Marta,Martins Ana PaulaORCID,Sepodes Bruno

Funder

Imlygic applied the durable response rate

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference34 articles.

1. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004;Anon;Off. J. Eur. Union,2007

2. Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products;Anon;Off. J. Eur. Union,2009

3. Regulatory and scientific advancements in gene therapy: state-of-the-art of clinical applications and of the supporting European Regulatory Framework;Carvalho;Front. Med.,2017

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

5. Clinical development and commercialization of advanced therapy medicinal products in the European Union: how are the product pipeline and regulatory framework evolving?;Boráň;Hum. Gene Ther. Clin. Dev.,2017

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