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

ABSTRACT: 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 Latin America region by examining the similarities between regulatory requirements and reconciling their potential discrepancies through discussions among all national regulatory representatives. The core dossier was used in the submission of a new small molecule, NME1, to nine markets. Assessment of the process included the time to submission; the timing, number, and complexity of questions received; and timing of final national regulatory agencies (NRA) evaluation decisions. The core dossier resu

SUBMITTER: Alvarez AL 

PROVIDER: S-EPMC10229127 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature