Regulatory challenges for autologous tissue engineered products on their way from bench to bedside in Europe

Author:

Ram-Liebig Gouya,Bednarz Juergen,Stuerzebecher Burkard,Fahlenkamp Dirk,Barbagli Guido,Romano Giuseppe,Balsmeyer Ulf,Spiegeler Maria-Elsa,Liebig Soeren,Knispel Helmut

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference41 articles.

1. Regulation (EC) No 1394/2007 of the European Parliament and of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004;Off. J. Eur. Union,10122007

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;Off. J. Eur. Union,2009

3. Tissue engineering for the lower urinary tract: a review of a state of the art approach;Sievert;Eur. Urol.,2007

4. Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols;Madry;European Cell Mater.,2014

5. Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with article 17 of regulation (EC) No 1394/2007 (online available at www.ema.europe.eu)

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