Regulatory pathway for pharmaceutical drug product registration and export in Gulf countries

Abstract

The Indian pharmaceutical market is the third largest in terms of generic production. It has developed a reputation as a center of industry and research in the international market. India offers some of the costeffective manufacturing facilities globally. The Gulf cooperation council (GCC) region is regarded as a “developing market for pharmaceutical export”. This study assessed the regulatory frameworks of the GCC member countries of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE) to build a coordinated approach. GCC regions are exposed to a partially regulated market. Most regulatory changes and developments must be kept up to date by pharmaceutical businesses, and GCC adopted the international council for harmonization common technical document (ICH CTD) format for new product registration. To fulfill the public demand for safe and effective treatments, regulations are needed for pharmaceutical drug products urgently due to rising healthcare costs, R&D expenditures, and other factors. Harmonizing the data on quality, safety, and efficacy reported in the application dossier is a main concern for the ICH committee. This review article provides the regulatory framework of GCC countries for effective control of pharmaceutical products.