Stages of the pharmaceutical business development are connected with medicinal tragedies in days past, which date back not only to history, but even now such facts are often recorded in the global pharmaceutical business. Drug manufacturing, distribution and quality control defects, also patient health complications caused by them are the problem of a global nature. There is no state the pharmaceutical business and regulatory service of which do not have involuntary or intentional deviations. The introduction provides a general description of the existing approaches and models of the regulation of the indicated sphere. The first chapter of the thesis considers the “Theoretical and Methodological Basis for the international pharmaceutical business regulation”, which includes the basic requirements and standards of regulations existing internationally in this business, as well as the regulation of pharmaceutical activity and drugs and their legal basis. The second chapter of the thesis "The introduction of international regulations in the practice of the pharmaceutical business", in which the introduction of the relevant standards of regulation of GMP and the industry in Georgian pharmaceutical companies is considered. The third chapter “Ways to improve the regulations of the pharmaceutical business,” includes ways to improve the regulation of the pharmaceutical business and improvement actions to improve the efficiency of pharmaceutical companies.