Russian Federation

Russian Federation

State Register of Medicines (GRLS)

Verified on December 2, 2022

The Russian Federation has a clinical trials registry, State Register of Medicines (GRLS). 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. There is no legal requirement to register a protocol on the registry. Results are not posted in the registry, but are allowed to be posted in 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
GRLS Countries with their own Registries/Database Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

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
GRLS Registration

Yes

Not yet specified
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.