Clinical Development of Gene Therapy Needs a Tailored Approach: A Regulatory Perspective from the European Union-Reference-Cited by-同舟云学术

Clinical Development of Gene Therapy Needs a Tailored Approach: A Regulatory Perspective from the European Union

Published:2014-03 Issue:1 Volume:25 Page:1-6
ISSN:2324-8637
Container-title:Human Gene Therapy Clinical Development
language:en
Short-container-title:Human Gene Therapy Clinical Development

Author:

Narayanan Gopalan¹,Cossu Giulio²³,Galli Maria Cristina⁴⁵,Flory Egbert²⁶,Ovelgonne Hans²⁷,Salmikangas Paula²⁸,Schneider Christian K.²⁹¹⁰,Trouvin Jean-Hugues¹¹¹²

Affiliation:

1. Biologicals Advice Limited, KT3 3AP Surrey, United Kingdom.

2. Committee for Advanced Therapies, European Medicines Agency, E14 4HB London, United Kingdom.

3. Institute of Inflammation and Repair, University of Manchester, M13 9PL Manchester, United Kingdom.

4. Gene Therapy Working Party of the Committee for Advanced Therapies, European Medicines Agency, E14 4HB London, United Kingdom.

5. Istituto Superiore di Sanita'Viale Regina Elena, 00161 Rome, Italy.

6. Division Medical Biotechnology, Paul-Ehrlich-Institut, 63225 Langen, Germany.

7. Dutch Medicines Evaluation Board, 3531 AH Utrecht, The Netherlands.

8. Finnish Medicines Agency, 00034 Helsinki, Finland.

9. Danish Health and Medicines Authority, 2300 Copenhagen, Denmark.

10. Twincore Centre for Experimental and Clinical Infection Research, 30625 Hannover, Germany.

11. Biologicals Working Party of the Committee for Human Medicinal Products, European Medicines Agency, E14 4HB London, United Kingdom.

12. School of Pharmacy, Paris Descartes University, 75006 Paris, France.

Publisher

Mary Ann Liebert Inc

Subject

Genetics (clinical)

Link

http://www.liebertpub.com/doi/pdf/10.1089/humc.2013.230

Reference6 articles.

1. The Committee for Advanced Therapies' of the European Medicines Agency Reflection Paper on Management of Clinical Risks Deriving from Insertional Mutagenesis

2. Lessons Learned from the Clinical Development and Market Authorization of Glybera

3. Pioneering gene therapy on brink of approval

4. Regulatory evaluation of Glybera in Europe — two committees, one mission

5. Glybera and the future of gene therapy in the European Union

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