The aim of the study was to identify problems and evaluate approaches to their solution for the sustainable development of the pharmacovigilance system of the registration certificate holder. The study materials were the results of the literature review and experimental studies conducted at the previous stages. Based on the analysis of external and internal factors of the FN MAN system, strengths, weaknesses, as well as threats and opportunities for improving the efficiency of the FN MAN system were identified. The main method used in the study was SWOT analysis. As a result of the SWOT analysis, the following were identified: — Strengths for realizing the capabilities of the external environment of the pharmacovigilance MAH system; — Opportunities for overcoming weaknesses that affect the achievement of the organization's goals; — Strengths of the system that must be used to eliminate threats; — Weaknesses that must be eliminated to minimize threats to the effective functioning of the pharmacovigilance system. The conducted SWOT-analysis defined the main areas of activity in the field of further improvement of the pharmacological safety system. Namely: — It is advisable to further introduce into the practical activities of medical institutions systems for supporting the adoption of medical and management decisions and methods for predicting the risks of using drugs; — It is necessary to improve organizational and management decisions for developing processes at different stages of drug circulation in order to strengthen the work of the spontaneous reporting system and the pharmaceutical system as a whole; — The central role of the MAH in the development of risk management approaches at all stages of the drug life cycle should be increased; — The need to develop and implement methodological approaches to strengthen the interaction of the MAH with representatives of other entities involved in the circulation of drugs has been identified; — The need to develop and implement training programs at various levels has been identified, taking into account the roles and responsibilities of specialists to prepare competent and trained specialists with appropriate professional training; — It is necessary to develop new models for a comprehensive assessment of the risks of using medicinal products at all stages of the medicinal product life cycle.

pharmacovigilance, drug safety, drug risk management, integrated risk assessment, marketing authorization holder.