A working meeting was held at the State Expert Center of the Ministry of Health of Ukraine with representatives of the clinical research market to improve the mechanism for submitting electronic applications for clinical trials and substantial amendments to the MoH Single Window via the Applicant's Electronic Cabinet.
During the meeting, the participants discussed technical and organizational issues that arise for applicants when submitting documents in electronic format.
The event was chaired by Yevheniia Ishkova, Deputy Director for HTA and Clinical Trials of the Center, with the participation of experts in the review of clinical trial materials and software specialists. Representatives of the Clinical Trials Subcommittee of the European Business Association, MSD-Ukraine and AstraZeneca also joined the discussion. More than 30 participants joined the discussion online.
According to Yevheniia Ishkova, the introduction of electronic submission of applications for clinical trials is an important step in the digitalization of regulatory services and the development of modern mechanisms of interaction with applicants.
"Such meetings give us the opportunity to hear the needs of the market and to improve digital tools taking these needs into account," emphasized Yevheniia Ishkova. "The proposals voiced during the discussion will be processed by the Center's specialists as soon as possible."
As is known, the possibility of submitting electronic applications for clinical trials and substantial amendments through the Single Window of the MoH has been available since April 2026. Now the entire process – from submitting an application to its approval – can be completed remotely, without visiting the Center.
The new functionality optimizes the procedure for submitting documents and the process of their review, and increases convenience for market representatives – by analogy with the mechanisms that already work successfully within eCTD.
Separately, during the meeting the participants touched upon the issue of improving the electronic Register of Clinical Trials in Ukraine https://clinicaltrials.dec.gov.ua/. The Center has currently developed a new interface for the platform, and work is ongoing to improve the mechanisms for searching and displaying information.
