Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil-Reference-Cited by-同舟云学术

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Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil

Published:2023-10-10 Issue:1 Volume:58 Page:21-33
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Fachel Flávia Nathiely Silveira^ORCID,Schuh Roselena Silvestri,Grudzinski Patrícia Bencke,Teixeira Helder Ferreira,Baldo Guilherme,Matte Ursula

Funder

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

https://link.springer.com/content/pdf/10.1007/s43441-023-00578-2.pdf

Reference25 articles.

1. Pimenta C, Bettiol V, Alencar-Silva T, Franco OL, Pogue R, Carvalho JL, Felipe MSS. Advanced therapies and regulatory framework in different areas of the globe: past, present, and future. Clin Ther. 2021;43:e103–38.

2. Iglesias-López C, Agustí A, Obach M, Vallano A. Regulatory framework for advanced therapy medicinal products in Europe and United States. Front Pharmacol. 2019;10:1–14.

3. Iglesias-Lopez C, Obach M, Vallano A, Agustí A. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States. Cytotherapy. 2021;23:261–74.

4. Flory E, Reinhardt J. European regulatory tools for advanced therapy medicinal products. Transfusion Medicine and Hemotherapy. 2013;40:409–12.

5. Bachtarzi H. Ex vivo and in vivo genome editing: A regulatory scientific framework from early development to clinical implementation. Regenerative Med. 2017;12:1015–30.

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