RNA-based drugs and regulation: Toward a necessary evolution of the definitions issued from the European union legislation.

Guerriaud, Mathieu; Kohli, Evelyne

Guerriaud, Mathieu; Kohli, Evelyne.

Afiliação

Guerriaud M; CREDIMI Laboratory EA 7532 and Laboratory of Excellence LipSTIC ANR-11-LABX-0021, Faculty of Health Sciences (Pharmacy), University of Burgundy, Dijon, France.
Kohli E; UMR INSERM/uB/AGROSUP 1231, Team 3 HSP-Pathies, Labelled Ligue Nationale Contre le Cancer and Laboratory of Excellence LipSTIC ANR-11-LABX-0021, Faculty of Health Sciences (Pharmacy), University of Burgundy, Dijon, France.

Front Med (Lausanne) ; 9: 1012497, 2022.

Article em En | MEDLINE | ID: mdl-36325384

Palavras-chave

EMA; FDA; ICH; RNA-based drugs; advanced therapy medicinal products (ATMP); biological medicinal products; gene therapy medicinal products (GTMP); mRNA vaccines

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Front Med (Lausanne) Ano de publicação: 2022 Tipo de documento: Article País de afiliação: França País de publicação: Suíça

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