Russian Federation

Russian Federation

Clinical-Trials.ru

Verified on September 8, 2021

The Russian Federation has a clinical trials registry, Clinical-Trials.ru. It is not a World Health Organization (WHO) recognized primary registry. The main purpose of the registry is to give an outline of the clinical trials, conducted in the Russian Federation. The Russian Ministry of Health and the Drug Regulatory Agency, Roszdravnadzor are conjointly in charge of approving a trial and posting the trial information for public access. It is a mandatory requirement to register a protocol on the registry. The results are not posted in the registry. However, results are allowed to be posted on the global registry, ClinicalTrials.gov.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
Clinical-Trials.ru Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 2-4);

Observational

Russian
Registry of Issued Permits for Clinical Trials of Drugs Academic/Patient Registries/Voluntary Patient organization Patient

Interventional

Phase 1-4
Russian
Registration and Results Requirements
Registry Activity Legal Requirement Timing
Clinical-Trials.ru Registration

Yes

After the approval from the Ministry of Health according to the Russian Federal Law on the Circulation of Medicines; and Russia’s Federal Service on Surveillance in Healthcare, Roszdravnadzor and after subject enrollment
Results

No

Not applicable (NA)
Registry of Issued Permits for Clinical Trials of Drugs Registration

No

NA
Results

No

NA

Registry Updates


References


  1. Federal Law on Circulation of Medicines. UNODC. https://roszdravnadzor.gov.ru/drugs/controllslp/documents/66. Published April 12, 2010. Accessed July 13, 2020.
  2. Regulation of Circulation of the Medical Devices in Russian Federation. Federal Service for Surveillance in Healthcare. http://www.roszdravnadzor.ru/i/upload/files/Medical%20devices/%D0%94%D0%9E%D0%9A%D0%9B%D0%90%D0%94%20%20%D0%90%D0%9D%D0%93%D0%9B%202017_10_26.pdf. Published October 26, 2017. Accessed November 14, 2018.
  3. Ministry of Health of the Russian Federation-Order. IMEDA. http://www.imeda.ru/netcat_files/32/30/order_no_2n_from_09_01_2014.pdf. Published January 9, 2014. Accessed November 10, 2018.