As of 21 April 2018, developers of pharmaceuticals (the Applicants) are required to follow the adopted procedure if they wish to obtain a permit for a clinical trial for their pharmaceuticals.
The state agency responsible for issuing clinical trial permits is the Ministry of Healthcare of the Russian Federation.
The Applicant can submit the application form for a clinical trial permit to the Ministry together with the accompanying documentation electronically.
The Ministry must consider the application and issue a permit within 40 working days from the day it receives the application and the accompanying documentation.
In order to obtain a permit, the Applicant must submit to the Ministry in paper form and electronically the application (in the form provided in the annex to the adopted administrative regulation), accompanied with the required documents that include:
- clinical trial protocol;
- information on the experience of researchers in relevant specialties and their experience in conducting clinical trials of medicines/pharmaceuticals;
- information on medical institutions where the trial is to take place;
- a copy of the compulsory insurance contract, indicating the maximum number of patients participating in the clinical trial;
- information on the composition of the medicinal product, etc.
For documents are composed in a foreign language, certified translations into Russian must be attached.
Law: Order No. 20n of 19 January 2018 on the Approval of the Administrative Regulation on Issuing Permits for Clinical Trials for Medicines