Abstract

REGULATORY ASPECTS AND DOSSIER FILING FOR GENERIC PRODUCTS IN MIDDLE EAST COUNTRIES

A. Venkateswarlu*, M. V. Nagabhushanam and M. Beena Devi

Abstract

The regulatory approval and dossier filing for generic products in Middle Eastern countries involve adhering to diverse frameworks and addressing country-specific requirements. While efforts like the GCCDR streamline processes across Gulf Cooperation Council countries, manufacturers must also meet localized demands such as Arabic labeling, Zone IVb stability studies, and compliance with specific packaging standards. The preparation of a Common Technical Document (CTD), supported by robust bioequivalence studies and GMP-compliant production, is central to the approval process. Despite challenges like regulatory variability and prolonged timelines, the region presents significant opportunities for generic manufacturers due to its growing demand for affordable pharmaceuticals and healthcare services.

Keywords: Middle Eastern countries, Generic products, Common Technical Document (CTD).