Results of the expert survey assessing the efficiency level of the national regulatory system in the field of medicines turnover

Maxim Suvorov, Alla Kotvitska
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 Materials and methods. The research materials consisted of the results of a survey conducted among government officials of national regulatory authorities in the field of medicines circulation. The research utilized methods of sociological survey, descriptive statistics, graphical analysis, data grouping, and generalization techniques. The research includes the development of a questionnaire based on the World Health Organization's \"Global Benchmarking Tool\" methodology, adapted to the national healthcare system. The questionnaire consisted of 2 questions to determine respondent characteristics and 104 statements about the functioning of the national regulatory system in the field of drug circulation. 
 Results. According to 75 % of the surveyed officials in Ukraine, an effective regulatory system operates in the field of drug circulation. Based on the number of affirmative answers, all statements were divided into 4 groups: high, sufficient, moderate, and low. Thus, the quality management system of national regulatory authorities was evaluated at a high level, while the funding system of national regulatory authorities received the lowest ratings. The grouping allowed us to identify weaknesses in the activity of the national regulatory system in the field of drug circulation, such as the lack of funds in budgets for staff training and overall insufficient funding for national regulators, including insufficient funding from international donors, lack of clarity and comprehensiveness in the regulatory framework for the pharmaceutical sector, etc. 
 Conclusions. In accordance with the aim of the article, we conducted research on the efficiency level of the national regulatory system in the field of drug circulation, which revealed that the most mature and effective direction of its activity today is the development and implementation of quality systems in national regulatory authorities","PeriodicalId":30651,"journal":{"name":"ScienceRise","volume":"49 3","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ScienceRise","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.15587/2519-4852.2023.290086","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract

The aim. The aim of the research is to analyze the efficiency level of the national regulatory system in the field of medicines circulation using self-diagnostic tools, which will allow identifying reserves for its optimization and further improvement. Materials and methods. The research materials consisted of the results of a survey conducted among government officials of national regulatory authorities in the field of medicines circulation. The research utilized methods of sociological survey, descriptive statistics, graphical analysis, data grouping, and generalization techniques. The research includes the development of a questionnaire based on the World Health Organization's "Global Benchmarking Tool" methodology, adapted to the national healthcare system. The questionnaire consisted of 2 questions to determine respondent characteristics and 104 statements about the functioning of the national regulatory system in the field of drug circulation. Results. According to 75 % of the surveyed officials in Ukraine, an effective regulatory system operates in the field of drug circulation. Based on the number of affirmative answers, all statements were divided into 4 groups: high, sufficient, moderate, and low. Thus, the quality management system of national regulatory authorities was evaluated at a high level, while the funding system of national regulatory authorities received the lowest ratings. The grouping allowed us to identify weaknesses in the activity of the national regulatory system in the field of drug circulation, such as the lack of funds in budgets for staff training and overall insufficient funding for national regulators, including insufficient funding from international donors, lack of clarity and comprehensiveness in the regulatory framework for the pharmaceutical sector, etc. Conclusions. In accordance with the aim of the article, we conducted research on the efficiency level of the national regulatory system in the field of drug circulation, which revealed that the most mature and effective direction of its activity today is the development and implementation of quality systems in national regulatory authorities
评估药品周转领域国家监管体系效率水平的专家调查结果
的目标。本研究的目的是利用自诊断工具分析国家药品流通领域监管体系的效率水平,为其优化和进一步改进提供储备。& # x0D;材料和方法。研究材料包括对药品流通领域国家监管当局的政府官员进行的调查结果。本研究运用了社会学调查、描述性统计、图形分析、数据分组和概化等方法。这项研究包括根据世界卫生组织的“全球基准工具”方法编制一份调查问卷,以适应各国的卫生保健系统。问卷包括确定受访者特征的2个问题和关于药品流通领域国家监管体系运作的104个陈述。& # x0D;结果。在乌克兰接受调查的官员中,75%的人认为在药品流通领域有一个有效的管理制度。根据肯定答案的数量,将所有陈述分为4组:高、足够、中等和低。因此,国家监管机构的质量管理体系得到了较高的评价,而国家监管机构的资助体系得到了最低的评价。分组使我们能够确定国家监管系统在药品流通领域活动中的弱点,例如缺乏用于工作人员培训的预算资金和国家监管机构的总体资金不足,包括国际捐助者的资金不足,制药部门监管框架缺乏明确性和全面性等。结论。根据本文的目的,我们对药品流通领域的国家监管体系的效率水平进行了研究,结果表明,当今其活动最成熟和有效的方向是国家监管部门质量体系的制定和实施
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