Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US-Reference-Cited by-同舟云学术

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Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US

Published:2022-09 Issue: Volume:26 Page:74-83
ISSN:2329-0501
Container-title:Molecular Therapy - Methods & Clinical Development
language:en
Short-container-title:Molecular Therapy - Methods & Clinical Development

Author:

Tajima Gentaro^ORCID,Huh Seoan,Schmidt Natalie Anne,Macdonald Judith C.,Fleischmann Tobias,Wonnacott Keith Merrell

Funder

CMC Microsystems

Publisher

Elsevier BV

Subject

Genetics,Molecular Biology,Molecular Medicine

Reference48 articles.

1. Gene therapy;High;N. Engl. J. Med.,2019

2. Gene therapy comes of age;Dunbar;Science,2018

3. The approved gene therapy drugs worldwide: from 1998 to 2019;Ma;Biotechnol. Adv.,2020

4. Delivering Promising New Medicines without Sacrificing Safety and Efficacy,2019

5. Wiley Database on Gene Therapy Trials Worldwide;Gene Therapy Net,2021

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1. The science and practice of current environmental risk assessment for gene therapy: a review;Cytotherapy;2024-07

2. Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures;Expert Opinion on Biological Therapy;2024-06-02

3. Delivery of gene therapy in haemophilia treatment centres in the United States: Practical aspects of preparedness and implementation;Haemophilia;2023-09-25

4. Unlocking the value of innovative medicines: Insights from the advanced therapy medicinal products (ATMP) innovation systems in Germany and Sweden;Health Policy and Technology;2023-06

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