Browsing by Author "Anas Islam, Vazahat Ali"

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    Regulations in Gulf Cooperation Council (GCC) Countries
    (CRC Press, 2024) Usama Ahmad; Anas Islam, Vazahat Ali
    This chapter explores the regulations governing Active Pharmaceutical Ingredient (API) drug products in the Gulf Cooperation Council (GCC) countries. It provides an overview of the GCC countries, defines APIs, and emphasizes the importance of API regulations within the region. The chapter aims to examine the regulatory framework for APIs in the GCC countries, comparing the specific regulations in Saudi Arabia, United Arab Emirates (UAE), Kuwait, Bahrain, Oman, and Qatar. To begin, the chapter delves into the general regulatory landscape surrounding APIs in the GCC countries, outlining the registration and approval processes for these crucial components of pharmaceutical products. It also highlights the post-approval requirements and monitoring mechanisms that ensure the ongoing safety and efficacy of APIs. In a comprehensive comparison, the chapter presents a detailed analysis of API regulations in each GCC country. By exploring the specific regulatory frameworks of the GCC countries, readers gain valuable insights into the similarities, differences, and unique approaches employed by each country. Additionally, the chapter addresses the challenges and issues faced in API regulations within the GCC countries. It explores compliance challenges, quality control concerns, intellectual property considerations, and the difficulties associated with harmonization. Furthermore, the chapter offers a forward-looking perspective by discussing potential future trends that may impact API regulations in the region. In conclusion, this chapter summarizes the key points discussed throughout the analysis. It underscores the significance of API regulations in the GCC countries and their impact on public health and the pharmaceutical industry. Finally, it highlights the potential for future developments in API regulations, emphasizing the need for continued attention and adaptation to meet evolving regulatory requirements and ensure the safety and quality of pharmaceutical products within the GCC countries.