Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region

The Latin America region comprises several countries that do not follow harmonized regulatory requirements for drug product (DP) marketing authorization applications (MAA), resulting in customized registration dossiers for each country. Here, we established a core dossier for multiple MAA in the Lat...

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Detalles Bibliográficos
Autores principales: Alvarez, Alva Lucia, Maisonet, Irma O., Ruiz, Omar, Lumsden, Rebecca S., Ferreira, Ana Paula Evangelista, Avila Flores, Esther M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10229127/
https://www.ncbi.nlm.nih.gov/pubmed/37261120
http://dx.doi.org/10.3389/fmed.2023.1102452

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10229127/
https://www.ncbi.nlm.nih.gov/pubmed/37261120
http://dx.doi.org/10.3389/fmed.2023.1102452

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