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

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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Bibliographic Details
Main Authors: Alva Lucia Alvarez, Irma O. Maisonet, Omar Ruiz, Rebecca S. Lumsden, Ana Paula Evangelista Ferreira, Esther M. Avila Flores
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-05-01
Series:Frontiers in Medicine
Subjects:
convergence
harmonization
regulatory requirements
acceleration
simplification
divergence
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2023.1102452/full

Internet

https://www.frontiersin.org/articles/10.3389/fmed.2023.1102452/full

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