The analysis of the regulatory and legal support for clinical trials of medicines and veterinary preparations in Ukraine and the EU
DOI:
https://doi.org/10.24959/uekj.20.34Keywords:
clinical trials, medicine, veterinary preparation, research sponsor, informed consentAbstract
Aim. To analyze the regulatory and legal support for clinical trials of medicines and veterinary preparations in Ukraine and the EU.
Results. The analysis of normative documentation for clinical trials of medicines and veterinary preparations has determined significantly different approaches in Ukraine regarding the approved procedures, specified laboratories and clinical sites regulating communications between sponsors and researchers, information support of the procedure, availability of public information, reporting, etc. It has been proven that in veterinary medicine the regulatory framework for clinical trials in Ukraine needs to be updated, a number of critical procedures and documents for planning, monitoring, reporting and various forms of analysis have not been regulated. The absence of interconnection and harmonization of procedures for the use of animals in research has been determined. The main problems in the regulation of clinical trials in veterinary medicine remain the lack of transparent procedures, the absence of regulated guidelines for applicants and sponsors, the low quality of expertise and the lack of coordination between the various government agencies involved.
Conclusions. The regulatory and legal bases existing at the moment in Ukraine for conducting clinical trials of medicines complies with international standards and EU Directives. The lack of the regulatory and legal support has been proven; it requires and determines the conduct of clinical trials in veterinary medicine not only in the form of guidelines, but has legal force. Significantly different approaches have been identified regarding the procedures for conducting clinical trials, namely, human clinical trials focus on protecting the ethical standards of the study subject, while the first area of the current animal clinical trial standards is the development and testing of veterinary preparations at all levels, species of target animals; issues of the animal welfare and protection do not cover the legislative and regulatory framework for clinical trials.References
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