Results of the expert survey assessing the efficiency level of the national regulatory system in the field of medicines turnover
DOI:
https://doi.org/10.15587/2519-4852.2023.290086Keywords:
national regulatory systems, national regulatory authority, drug circulation, self-diagnosisAbstract
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
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