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 |
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Registry of Issued Permits for Clinical Trials of Drugs | Academic/Patient Registries/Voluntary | Patient organization | Patient |
Interventional Phase 1-4 |
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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
- July 2021: Clinical Trial Data Reporting in EU Countries - In Europe, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. Nearly 28% of completed European trials in the EU Clinical Trials Register (EUCTR) on 1 July—had not posted their results according to the latest data from the EU Trials Tracker, set up by U.K. researchers in … Continue reading "July 2021: Clinical Trial Data Reporting in EU Countries"
- July 2021: Russian Federation Regulatory Update - In Russia, the Registry of Approved Clinical Trials (RCT) is hosted by the State Register of Medicines. An update was posted on the State Register of Medicines notifying its users to change their passwords by 12 July 2021. This action has been undertaken to comply with the requirements of regulators in the field of information … Continue reading "July 2021: Russian Federation Regulatory Update"
- February 2020: What’s New on EudraCT - EudraCT has posted below notification: As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period. The transition period began on 1 February 2020 and is due to end on 31 December 2020.
References
- Federal Law on Circulation of Medicines. UNODC. https://roszdravnadzor.gov.ru/drugs/controllslp/documents/66. Published April 12, 2010. Accessed July 13, 2020.
- 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.
- 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.