Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation-Reference-Cited by-同舟云学术

Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation

Published:2017-11-06 Issue:1 Volume:103 Page:120-127
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Coppens Delphi G.M.¹,De Bruin Marie L.¹²,Leufkens Hubert G.M.¹,Hoekman Jarno¹³

Affiliation:

1. Utrecht/WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht Institute for Pharmaceutical Sciences; Utrecht University; Utrecht The Netherlands

2. Copenhagen Centre for Regulatory Science (CORS), Department of Pharmacy; University of Copenhagen; Copenhagen Denmark

3. Innovation Studies Group, Copernicus Institute for Sustainable Development; Utrecht University; Utrecht The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference54 articles.

1. Cell-based therapeutics: the next pillar of medicine;Fischbach;Sci. Transl. Med.,2013

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

3. Clinical development of gene therapy: results and lessons from recent successes;Kumar;Mol. Ther. Methods Clin. Dev.,2016

4. Clinical development and commercialization of Advanced Therapy Medicinal Products (ATMPs) in the EU: how are the product pipeline and regulatory framework evolving?;Boráò;Hum. Gene Ther. Clin. Dev.,2017

5. Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems;Pirnay;Cell Tissue Bank.,2013

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