MODERN APPROACHES TO ENSURING THE EFFECTIVENESS AND SAFETY OF MEDICINES IN UKRAINE

Abstract

The article examines contemporary approaches to ensuring the efficacy and safety of medicinal products in the healthcare system. The relevance of the problem is due to the growing number of new pharmaceutical and biotechnological drugs, increased requirements for the evidence of clinical results, as well as the persistence of significant risks associated with adverse reactions, counterfeiting, and improper drug quality control practices. The aim of the study is to analyze modern scientific and regulatory approaches to ensuring the efficacy and safety of medicines, identify key problems in this area, and formulate practical recommendations for improving the pharmacovigilance system and regulatory environment in Ukraine. The methodological basis was the analysis and generalization of scientific sources, the comparative legal method, and a systematic approach, which ensured a comprehensive review of all stages of the drug life cycle. The study found that global practice is based on an integrative model of drug quality control, which includes the principles of evidence-based medicine, multi-level clinical trials, a developed pharmacovigilance system, a harmonized regulatory framework (GMP, GDP, GCP, GSP), and innovative digital technologies. At the same time, Ukraine continues to face significant problems: insufficient effectiveness of pharmacovigilance, the spread of drugs with questionable evidence base, regulatory gaps in post-registration control, circulation of counterfeit drugs, low pharmaceutical culture of the population, and challenges related to military actions and logistical disruptions. The practical significance of the article lies in the development of a set of recommendations for improving the pharmacovigilance system, harmonizing national legislation with European standards, introducing digital control tools, and developing educational and information programs for healthcare professionals and patients. The proposed measures will contribute to the formation of a transparent and effective system for controlling the circulation of medicines, which will ensure a high level of safety and confidence in pharmacotherapy in Ukraine.