Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special Article: Advanced therapy medicinal products in Brazil: regulatory panorama

Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special Article: Advanced therapy medicinal products in Brazil: regulatory panorama

Advanced therapy medicinal products, considered special medications, requires Anvisa approval for use and commercialization in Brazil. They include the advanced cellular therapy products, tissue engineering products and gene therapy products, which due to their complexity involve innovation and risk...

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Bibliographic Details
Main Authors: João Batista Silva Junior, Antonio Alfredo Rodrigues e Silva, Francielli Cristine Cunha Melo, Melina Cossote Kumoto, Renata Miranda Parca
Format: Article
Language:English
Published: Elsevier 2021-11-01
Series:Hematology, Transfusion and Cell Therapy
Subjects:
Gene therapy
Advanced therapy medicinal product
Anvisa
Clinical trials
Regulatory approval
Online Access:http://www.sciencedirect.com/science/article/pii/S2531137921001462

Internet

http://www.sciencedirect.com/science/article/pii/S2531137921001462

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