What could gene therapies learn from orphan drugs’ post-regulatory approval access in the EU?-Reference-Cited by-同舟云学术

What could gene therapies learn from orphan drugs’ post-regulatory approval access in the EU?

Published:2019-09-02 Issue:9 Volume:7 Page:407-414
ISSN:2167-8707
Container-title:Expert Opinion on Orphan Drugs
language:en
Short-container-title:Expert Opinion on Orphan Drugs

Author:

Iskrov Georgi¹²,Vasilev Georgi³,Stefanov Rumen¹²

Affiliation:

1. Department of Social Medicine and Public Health, Faculty of Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria

2. Institute for Rare Diseases, Plovdiv, Bulgaria

3. Faculty of Medicine, Medical University of Plovdiv, Plovdiv, Bulgaria

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Health Policy,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

https://www.tandfonline.com/doi/pdf/10.1080/21678707.2019.1663171

Reference42 articles.

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

2. Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them

3. 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. OJ L 324, 10.12.2007, p. 121–137.

4. Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework

5. Challenges to orphan drugs access in Eastern Europe: The case of Bulgaria

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