A special recording procedure for certain securities will be in effect until the end of 2025

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23.04.2025

IT WILL BE POSSIBLE TO APPROVE CHANGES TO A DRUG TRIAL PROTOCOL IN ELECTRONIC FORM

The procedure for reviewing a message about the need to amend a drug clinical trial protocol has been updated. Starting in 2026, organizations conducting clinical trials must send it through the State Information System in the field of healthcare to the personal account of the Ministry of Health, and before 2026 - by mail on paper. The message is registered within a working day. Within 28 working days, the Ministry of Health makes a decision on amending the protocol or refusing to do so and sends it to the applicant's personal account in the State Information System.

To assess the validity of the proposed changes and determine the degree of risk to patients participating in clinical trials, the Ministry of Health may, within 3 working days after receiving the message, send a request and involve experts from the ethics council and the budgetary institution in its review, who should submit a conclusion to the Ministry within 20 working days.

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