Study Approval Process

Cromos Pharma has extensive experience interacting with the various departments of Russian regulatory authorities. Understanding, communicating, and working with the Russian Ministry of Health can significantly reduce the time to market for any project. By designing a study that integrates a full understanding of current regulations and the regulatory environment from the start, we can help assure that the drug development process runs more smoothly and efficiently.

The whole approval process takes 4 to 8 weeks.

1 - Submission of clinical trial documents
2 - National Ethics Committee remarks
3 - Contract sponsor/investigators
4 - Permission for clinical trial
5 - Approval at the Scientific Centre
6 – Approval at the Clinical Trials Control Department
7 - Certificate on clinical trial progress
8 – Approval by Pharmacology Committee
9 – Patient’s insurance

The application file in 2 copies has to be submitted to the Ministry of Health, Department for State Control of Quality, Efficacy and Safety of Medicinal Products and Medical Devices. After registration, one copy is passed to the Scientific Center for Expertise and State Control of Medicinal Products. If the file is considered to be satisfactory, it proceeds to the Pharmacological Committee. Simultaneously, the other copy is passed to the central ethics committee, which takes about 4 to 5 weeks for approval.

If the decisions of both central ethics committee and Pharmacological Committee are positive, the Department obtains final approval from the State Control of the Ministry of Health.