Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States-Reference-Cited by-同舟云学术

Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States

Published:2021-03 Issue:3 Volume:23 Page:261-274
ISSN:1465-3249
Container-title:Cytotherapy
language:en
Short-container-title:Cytotherapy

Author:

Iglesias-Lopez Carolina,Obach Mercè,Vallano Antonio,Agustí Antonia

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference34 articles.

1. European Medicines Agency. Committee for Advanced Therapies (CAT) Work Programme 2010 - 2015 [Internet]. 2020 [cited 2020 Aug 12]. Available from: https://www.ema.europa.eu/en/documents/work-programme/committee-advanced-therapies-cat-work-programme-2010-2015_en.pdf

2. European Medicines Agency. Reflection paper on classification of advanced therapy medicinal products [Internet]. 2010 [cited 2020 Mar 6]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-classification-advanced-therapy-medicinal-products_en-0.pdf

3. Regulatory framework for advanced therapy medicinal products in Europe and United States;Iglesias-Lopez;Regulatory watch: European,2019

4. Regulatory watch: European regulatory experience with advanced therapy medicinal products;Barkholt,2019

5. Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States;Iglesias-Lopez,2019

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