Peculiarities of Implementation of The Concept of Providing Quality of Drugs in Ukraine

Abstract

The modern quality assurance of medicines covers the quality assurance of drugs, from the stage of their pharmaceutical development, research, through proper production, quality control, storage, implementation and the provision of information to the physician and patient. According to this concept, reliable guarantees of quality and safety of the drug should be provided at all stages of the drug life cycle. The quality of each drug should be proven at the stages of preclinical studies and clinical trials, objectively evaluated in the case of state registration, securely secured in the course of industrial serial production, and constantly controlled in the wholesale, retail and medical applications. In the focus of the WHO’s recommendations, all areas of the implementation of the concept of quality assurance of drugs should be aimed at meeting the needs of patients. The aim of the work was to analyze the modern system of quality assurance of medicines at all stages of their advancement in the pharmaceutical market of our country and to focus on the main problems that hinder the transition of the domestic pharmaceutical industry to international and European standards.