THE LEGAL INCORPORATION OF WHO GOOD MANUFACTURING PRACTICES IN GCC PHARMACEUTICAL LEGISLATION: FROM SOFT LAW TO HARD LAW

Pharmaceutical manufacturing has been extensively examined from technical and economic perspectives. Nevertheless, insufficient focus has been placed on its legal regulation, especially in the Gulf region. This study examines the legal incorporation of WHO Good Manufacturing Practices (GMP) into the Gulf Cooperation Council's (GCC) pharmaceutical legislation and the mechanisms that ensure pharmaceutical quality and integrity. The proliferation of substandard and counterfeit medical products endangers patients and undermines trust in national healthcare systems. The paper adopts an inductive and analytical doctrinal approach and examines relevant pharmaceutical legislation in the United Arab Emirates, the Kingdom of Saudi Arabia, and Qatar. It analyses statutory standards imposed on manufacturing practices, licensing requirements, marketing controls, and supervisory mechanisms. This study highlights the need to strengthen legal coordination and clarify compliance standards, thus ensuring the integrity of pharmaceutical manufacturing and effectively transforming WHO GMP from soft guidelines into binding legal obligations within the GCC legal framework.