ПРОГАЛИНИ У РЕГУЛЯЦІЇ ПРОВЕДЕННЯ КЛІНІЧНИХ ДОСЛІДЖЕНЬ МЕДИЧНИХ ВИРОБІВ ТА МЕДИЧНИХ ВИРОБІВ ДЛЯ IN VITRO ДІАГНОСТИКИ В УКРАЇНІ

Abstract

The article summarizes the arguments and counterarguments within the scientific debate on the issue of gaps in the regulation of clinical research of medical devices and medical devices for in vitro diagnostics in Ukraine. The main goal of the conducted research is to identify an exhaustive list of such gaps and develop recommendations for improving the mentioned regulations. The systematization of literary sources and approaches to solving the problem of gaps in the regulation of clinical research of medical devices and medical devices for in vitro diagnostics in Ukraine proved that the scientific discussion on this topic is not conducted in Ukraine, despite the presence of WHO recommendations on the revision of relevant legal acts . The urgency of solving this scientific problem lies in the fact that filling the gaps in the relevant regulations and harmonizing the regulations with the relevant regulations of the European Union is an integral part of the recognition of clinical evidence on the effectiveness and safety of medical devices obtained during research in Ukraine by European regulatory authorities. Filling these gaps could potentially lead to increased demand for clinical trials of medical devices and medical devices for in vitro diagnostics in Ukraine. The results of the empirical analysis of the market of clinical research of medical products in Ukraine, in comparison with clinical research of medicinal products in Ukraine, proved that Ukraine is more attractive for conducting clinical research of medicinal products. This trend is explained, in particular, by the presence of specialized regulation of clinical trials of medicinal products in Ukraine, the presence of a body responsible for supervision, audit, and evaluation of the results of such clinical trials. The study empirically confirms and theoretically proves that the regulation of this area is insufficient, which leads to the need for additional examination of research materials abroad, and therefore to lower interest in conducting clinical research of medical devices in Ukraine. The results of the conducted research may be useful to regulatory bodies for the development of a regulatory framework for conducting clinical trials of medical devices and products for in vitro diagnostics in Ukraine, sponsors of such trials and contractor companies performing such trials in Ukraine