Analysis and comparative evaluation of expedited programs for gene therapy products: insights from the United States, the European Union, Japan, and South Korea

Author:

Jeong HyeokgyoORCID,Purja SujataORCID,Kim EunyoungORCID

Funder

National Research Foundation of Korea

Publisher

Springer Science and Business Media LLC

Subject

Genetics,Molecular Biology,Molecular Medicine

Reference64 articles.

1. Regulation E. 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

2. (EC) no 726/2004. Off J Eur Union 2007; 324: 121-37.

3. High KA, Roncarolo MG. Gene therapy. N Engl J Med. 2019;381:455–64.

4. Precedence Research. Cell and Gene Therapy Market Size to Surpass USD 93.78 BN by 2030. 2022. https://www.globenewswire.com/en/news-release/2022/11/30/2564827/0/en/Cell-and-Gene-Therapy-Market-Size-to-Surpass-USD-93-78-BN-by-2030.html.

5. EU. 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;242:3–12.

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