ACTO believes the Investigators’ rights in Russia are compromised.

ACTO noted that the medical organizations’ rights in regards of clinical trials are violated. The Association applied to the minister to protect the rights and to settle the issue.

ACTO states that The Order 683 dated 3.09.2020 is no more effective since January 2021. It states the rules for the medical Institutions to be accredited for the clinical trials. The Law was amended, however, no changes were introduced in the electronic registry. This is the topic of the ACTO’s letter.

The existing contradictions made it difficult for organizers and Sponsors to apply submissions and obtain study approvals.

First, the applicant is obliged to choose a register specified company. But current data evidence that MoH has not updated the list since 2020. The result is as follows: the clinical study institutions are either missing from the list, or information is compromised. A similar situation occurs when the institution data are amended.

The registry simply does not have a function for entering additional data or editing. The Ministry of Health says that information about the institution should be sent directly to the address of the ministry in paper form. No timelines are specified when the amendments are to be implemented. Such a system is not supported legally and significantly delays accepting clinical studies submissions.

ACTO declares that the situation requires an immediate solution. The issue was discussed with MoH, but the new system options are still not available.

ACTO demands for the Minister’s appropriate order. Amending the system will enable applicants to fully use their own right according to Federal Law No61 "On the circulation of Medicines". Currently, the rights of investigators in Russia remain violated.