Generic Pharmaceuticals Drug Registration Requirements and Technical Data Comparison Between all GCC Countries

Abstract

The Marketing Authorization Holder (MAH) is required to integrate technical specifications and various other documents about new pharmaceutical products to market them in different GCC countries. This research delves into the specific registration documentation necessary for the approval process of generic drugs in GCC (Gulf Cooperation Council) Countries. Each product must adhere to the distinct guidelines of the respective country it is seeking approval. The study focuses on the "Regulatory Guidelines for Generic Products Registration in GCC countries." Adhering to the guidance and regulations set forth by authoritative bodies such as the FDA (Food and Drug Administration), ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), and WHO (World Health Organization) streamline the filing process for pharmaceuticals in GCC countries, ensuring efficiency and accuracy. In the dynamic landscape of pharmaceutical generics, this research endeavors to elucidate the disparities in registration document requirements among GCC countries, particularly through the Common Technical Document (CTD) format. By delineating these discrepancies, stakeholders can better navigate the details of regulatory compliance and streamline the process of bringing generic pharmaceuticals to market in GCC countries