The article presents an analysis of the results of the implementation of measures to integrate the ophthalmological services of the Donetsk People's Republic and the Luhansk People's Republic into the healthcare system of the Russian Federation in the period 2023-2025 under the direct supervision of the Ministry of Health of the Russian Federation and with organizational and methodological supervision and practical support from the Helmholtz National Medical Research Center of Eye Diseases. The initial problems of the organization of ophthalmological services and the shortage of resources in new territories are considered, measures implemented to create a regional regulatory framework, territorial planning, improve the quality and accessibility of primary specialized ophthalmological care, increase the detection and improvement of the curation of ophthalmopathology among children, improve the quality and accessibility of inpatient, primarily surgical, care, as well as the results of therapeutic the work of the staff of the Helmholtz National Medical Research Center of Eye Diseases for the purpose of practical assistance to colleagues.

Keywords: ophthalmology, healthcare system integration, barriers to integration, successful integration outcomes, DPR, LPR, regional healthcare planning, patient routing, availability of medical care, quality control

Due to the growing volume of data, the efficiency of extracting data on the safety of drug use and signals directly depends on the level of automation of pharmacovigilance processes. Currently, the participants of the international pharmacovigilance system are actively considering the possibility of introducing AI both into the processes of IPR processing and signal detection, as well as for automating monitoring of literature and social media.

The purpose of the article is to analyze the use of artificial intelligence by pharmaceutical companies, regulatory agencies and other participants in the international pharmacovigilance system to identify safety data in open-source data.

The introduction of artificial intelligence can help reduce the time spent by specialists and improve the quality of monitoring information on the safety of medicines from open data.

Keywords: pharmacovigilance, drug safety, processing information messages about adverse reactions to medicines, artificial intelligence, digitalization, literary monitoring, social media

The implementation of the post-registration phase of studies largely depends on the high-quality functioning of the pharmacovigilance system. Its effectiveness during this period of medicinal product circulation depends on the timely reporting of new adverse reaction (AR) cases to the regulatory authority and other authorized pharmacovigilance officials. This article presents an analysis of the current status of collecting and recording cases of adverse reactions to medicinal products in the Republic of Tajikistan (using hospitals in Khatlon Oblast as an example). Data on documenting ARs to medicinal products for the period 2019-2024, recorded in registration logs, was collected. A total of 115 cases of adverse reactions involving 37 medications were identified in the 107 hospitals studied in the region (87% of all hospitals in the region, including cities and districts). These adverse reactions were not properly documented in accordance with legal requirements.

Based on the study, the authors concluded that the state of pharmacovigilance in Khatlon Region is unsatisfactory and proposed necessary measures to improve the pharmacovigilance system in hospitals to ensure the safe use of medications in pharmacotherapy.

Keywords: medicinal product, adverse reaction, accounting of cases of adverse reactions to medicinal products, documentation of adverse reactions, pharmacovigilance, hospital facilities, safe use of medicinal products, Republic of Tajikistan

The dynamics of regulatory changes reflect the pharmaceutical industry's transition from fragmented quality control of drugs manufactured in pharmacies to an integrated quality management system with internal audit.

The article presents an analysis of the transformation of the Russian regulatory framework governing the circulation of medicines, starting from the Soviet period and ending with the latest legislative innovations. The main stages are: centralized administrative management, licensing and accreditation, implementation of GxP and quality standards, development of internal audit. The aim of the study is to examine the impact of changes in economic conditions in the country and the principles of regulation of the development of internal audit in pharmacy organizations. The study examined the development of internal audit as an independent function in the quality management system, as well as the stages of its integration into the activities of pharmaceutical institutions. Key differences between the mechanisms of state federal control and internal control over compliance with requirements in the implementation of pharmaceutical activities by pharmacy organizations have been identified.

Keywords: government regulation, circulation of medicines, pharmacy organizations, pharmaceutical activities, internal quality control, internal audit in pharmacy organizations