The receipt of final NRA evaluation decisions was also accelerated in most markets, compared with the best-case approval timeframes. One round of queries of a low or medium complexity was received from all agencies. The core dossier resulted in an accelerated submission timeline for most markets and earlier receipt of NRA queries from some markets, compared with projections. 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 was used in the submission of a new small molecule, NME1, to nine markets. 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 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.
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