ABSTRACT

Drug products approval process in MENA as per the respective country regulatory requirements. The MENA region is one of the world's leading pharmaceutical market places. This thesis provides some common information to get a good understanding about the pharmaceutical market is organized, and marketing permits must be maintained in the MIDDLE EAST AND NORTH AFRICA region. Once the applicant acquires Marketing permission for the drug items. in any of the MENA region, then they can apply for the Marketing authorization of drug products in other MENA countries by using the previous MENA regions marketing authorization data. The process applies to all those who seek a Marketing authorization of drug products and each countries has their own application forms in their own language. This comprises information regarding user fee requirements, data to be submitted by the applicant as per the respective countries submission format by using CTD and eCTD submission techniques. Keywords: MENA, Marketing authorization, CTD, eCTD, Drug products
Publication date: 01/05/2025

https://ijbpas.com/pdf/2025/May/MS_IJBPAS_2025_89291.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.5.8929