Health Care, Clinical Trials

22/ 07/ 2019

Explanation on clinical trials documentation

On July 16, 2019, the EBA Clinical Trials Subcommittee (EBA CTS) received a letter from the Ministry of Justice of Ukraine providing clear explanations with references to the relevant regulatory acts, as regards the issues related to the clinical trials documentation.

Having analyzed the explanations, we can conclude that there is a possibility to further review the recommendations to the applicants regarding the numbering of clinical trials materials and variations. Certain simplifications would reduce the burden on companies’ departments that conduct clinical trials in Ukraine.

Thus, the way of resolving this issue will be further elaborated by the representatives of the EBA CTS and the State Expert Center.

We are grateful to the Ministry of Justice of Ukraine for providing useful and necessary explanations, which gives grounds for resolving this issue.

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