The Ministry of Health authorizes clinical trials in Russia within 31 working days. What Roszdravnadzor checks afterwards.
The Ministry of Health of Russia issues the authorization to conduct a clinical trial (CT) based on a document review and an ethical review. Roszdravnadzor supervises the trial after the authorization is issued: it monitors compliance with Good Clinical Practice (GCP) rules, receives safety reports on the investigational product, and suspends the trial if it finds violations that affect the completeness or reliability of the data.
Since 15 August 2026, the list of documents for the application also includes the results of preclinical safety and efficacy studies of the product, and the requirements for documents confirming the quality of the investigational product have been set out in a new wording. These changes were made by Federal Law No. 324-FZ of 4 August 2026 to Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines» (hereinafter Law No. 61-FZ).
An application is reviewed in 31 working days: 3 working days to check the documents, 25 for the reviews, and 3 for the decision. A request is an appeal by the Ministry of Health or the ethics council to the applicant. The applicant has up to 90 working days to answer it, and this time is not counted in the 31 working days.
As of October 2026, the state fee is RUB 140,000 for a standard or post-registration CT and RUB 215,000 for an international multicenter trial.
Who issues the authorization and what Roszdravnadzor does
The Ministry of Health of Russia issues the authorization as the authorized federal executive body. It maintains the register of issued authorizations and publishes it on its website. The Ministry makes its decision based on two reviews: a document review and an ethical review.
The document review is conducted by an expert institution, usually the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» (NCESMP). The ethical review is conducted by an ethics council, whose experts must not depend on drug developers or other parties interested in the results. The Ministry of Health sends review assignments to the personal accounts of both bodies in the unified system, and the conclusions arrive in the Ministry’s personal account.
Roszdravnadzor carries out federal state control (supervision) in the sphere of medicine circulation, and requirements for clinical trials fall within the subject of this control. If Roszdravnadzor finds violations of GCP rules that affect the completeness or reliability of the trial, it suspends the trial and issues the medical institution a corrective instruction. If the institution does not remedy the violations on time, Roszdravnadzor terminates the trial and sends a conclusion to the Ministry of Health, and the authorization is revoked on its basis.
The legal entity in whose name the CT authorization was issued is responsible for the safety of the product during the trial. It must receive, record, process, analyze, and store reports of adverse reactions, and it is liable under the law for failing to report or concealing information.
The pharmacovigilance procedure was approved by Roszdravnadzor Order No. 3518 of 17 June 2024 (hereinafter Order No. 3518) and applies from 1 March 2025 to 1 March 2031. Under it, reports of serious unexpected adverse reactions (SUSARs) and periodic safety reports on the investigational product (development safety update reports, DSURs) are submitted to Roszdravnadzor through the automated information system (AIS Roszdravnadzor).
What application rules have changed
GCP rules are now unified for the Eurasian Economic Union (EAEU) and are approved by the Eurasian Economic Commission (EEC). Clinical trials are conducted under Decision No. 79 of the Council of the EEC of 3 November 2016 «On Approval of the Good Clinical Practice Rules of the Eurasian Economic Union» (hereinafter Decision No. 79). Document exchange has moved to an electronic format: the provisions of Law No. 61-FZ on public services through the unified portal and the unified system have applied since 1 January 2026.
Since 15 August 2026, under Federal Law No. 324-FZ of 4 August 2026, the requirements for documents on the quality of the product have been set out in a new wording, and the list of documents includes the results of preclinical studies. The rules for signing the application changed earlier, on 1 March 2026.
Table 1. Before and after in the authorization procedure
| Parameter | Before | After |
|---|---|---|
| GCP rules | Order of the Ministry of Health No. 200n (until 1 September 2024) | EAEU GCP rules, Decision No. 79 of the Council of the EEC |
| Signing the application | The application is signed with an enhanced qualified electronic signature (UKEP) | Since 1 March 2026, the applicant signs with a UKEP. If a representative (an individual) acts, a machine-readable electronic power of attorney is required, and the representative may sign with a UKEP or an enhanced non-qualified electronic signature |
| Documents on the quality of the investigational product | A manufacturer’s document with the quality attributes (characteristics) of the product and information on the product manufactured for the CT | Since 15 August 2026, documents confirming the quality of the product manufactured for the CT, including the manufacturer’s document with quality attributes |
| Information on preclinical studies | The list of documents had no separate item | Since 15 August 2026, the list includes information on the results of preclinical safety and efficacy studies that justifies the use of the product, the routes of administration and the doses, for the relevant patient groups and the duration of the trial |
| Ethics council request | The law had no separate procedure for requesting materials | The request is sent to the applicant’s personal account, and the answer is due within 90 working days |
| Change of information in the authorization | The law had no separate procedure | The applicant applies through the personal account, and the review period is 28 working days |
Information on preclinical studies goes to the review together with the protocol and the investigator’s brochure, so the expert institution assesses the justification of doses and routes of administration together with the other trial materials. Answers to requests are signed with a UKEP, and there may be two requests: one from the Ministry of Health and one from the ethics council.
Documents, state fees, and timelines for obtaining the authorization
The application and documents are submitted through the unified public services portal or the Ministry of Health’s personal account in the unified system. Under Law No. 61-FZ, the package includes:
- Application for the authorization, signed with a UKEP
- Clinical trial protocol
- Investigator’s brochure. For a product registered under EAEU rules, it may be replaced by the approved summary of product characteristics (SmPC) if the use of the product in the trial does not contradict it
- Patient information sheet
- Information on the experience of the investigators in the relevant specialties and in conducting CTs
- Copy of the compulsory insurance contract stating the maximum number of patients
- Information on the composition of the product (except for biological medicinal products)
- Documents on the quality of the product manufactured for the CT (except for biological medicinal products)
- Documents and information required by EAEU rules for studies of biological medicinal products
- Information on the manufacturing license (for Russian sites) or on the Good Manufacturing Practice (GMP) compliance conclusion issued by the authority of the manufacturer’s country
- Information on the results of preclinical studies of safety and efficacy (since 15 August 2026)
The Ministry of Health requests information on payment of the fees through interdepartmental electronic interaction. The absence of this information is grounds for refusing to conduct the reviews. The amounts of the fees are set by the Tax Code of the Russian Federation (version of 4 August 2026).
Table 2. State fees for the reviews and the authorization
| Type of trial | Document review and ethical review | Issuance of the authorization | Total |
|---|---|---|---|
| Clinical trial | RUB 135,000 | RUB 5,000 | RUB 140,000 |
| International multicenter CT | RUB 210,000 | RUB 5,000 | RUB 215,000 |
| Post-registration CT | RUB 135,000 | RUB 5,000 | RUB 140,000 |
Under Law No. 61-FZ, an international multicenter trial is conducted by the product developer in different countries under a single protocol.
Table 3. Timelines for obtaining the authorization (in working days)
| Stage | Timeline |
|---|---|
| Check of the completeness and reliability of documents, decision to conduct the reviews, assignments to the expert institution and the ethics council | 3 working days from the date the application and documents are sent |
| Document review and ethical review, signing of conclusions | 25 working days from the date the assignments are sent |
| Assessment of conclusions, decision to issue or refuse, extract from the register | 3 working days from the date the conclusions are received |
| Applicant’s answer to a request of the Ministry of Health | Up to 90 working days from the date the Ministry of Health receives notice that the applicant received the request |
| Applicant’s answer to a request of the ethics council | Up to 90 working days on the same basis |
The maximum periods of the three stages without requests add up to 31 working days: 3, 25, and 3. A request of the Ministry of Health suspends the first three-day period from the date the request is sent to the date the answer is received. The time the applicant spends answering the ethics council is not included in the period of the ethical review.
The Ministry of Health refuses to conduct the reviews if the set of documents is incomplete, if there is no information on payment of the fee, or if the deadline for answering a request is missed. It refuses to issue the authorization if the experts or the ethics council conclude that the trial cannot be conducted. Both decisions can be appealed in the manner established by law.
A positive decision is issued as an extract from the register of issued authorizations, signed with a UKEP.
What happens after the authorization is issued
The investigator passes information on serious adverse events (SAEs) to the sponsor within 24 hours, and the sponsor’s period of 7 or 15 calendar days is counted from the date it receives this information. The medical institution where the trial is conducted does not itself report such reactions to Roszdravnadzor. The general periods of 3 working days and 15 calendar days in Order No. 3518 are set for reactions identified outside clinical trials.
Table 4. Obligations and timelines after the authorization is issued
| Event | Timeline | Who sends and to whom |
|---|---|---|
| Start of the trial | 3 working days from the start | The head of the medical institution notifies the Ministry of Health |
| Change of the protocol | The Ministry of Health reviews the notification within 28 working days | The trial organizer notifies the Ministry of Health |
| Clarification of information in the authorization | 28 working days to review the application | The applicant, through the personal account, with a reasoned justification |
| Completion, suspension, or termination | 5 working days | The trial organizer notifies the Ministry of Health |
| Report on trial results | 12 months from completion, suspension, or termination | The trial organizer submits it to the Ministry of Health |
| Serious adverse event at the trial site | Immediately, within 24 hours from the date it is identified | The investigator notifies the sponsor, except for events that the protocol or the brochure define as not requiring immediate notification |
| SUSAR that resulted in death or created a threat to life | Immediately, no later than 7 calendar days from the date the information is received | The sponsor sends it to Roszdravnadzor through the AIS |
| Other SUSARs | 15 calendar days from the date the information is received | The sponsor sends it to the same recipient |
| Follow-up report on a case of death or threat to life, if data was lacking | 8 calendar days after the first report | The sponsor sends it to the same recipient |
| New significant information on a SUSAR already submitted | 15 calendar days from the date it is received | The sponsor sends it to the same recipient |
| Other safety information that may change the assessment of the benefit-risk balance | 15 calendar days from the date it is received | The sponsor sends it to Roszdravnadzor, the investigators, and the ethics committees of the sites |
| Periodic safety report on the investigational product (DSUR) | The reporting period is one year; submission no later than 60 calendar days after data lock | The legal entity in whose name the authorization was issued sends it to Roszdravnadzor through the AIS |
The product developer or a person authorized by the developer, and educational and scientific organizations, may organize a trial. The developer may involve legal entities of any organizational and legal form in the organization. The principal investigator is appointed by the head of the medical institution and must have at least three years of experience in CT programs. Information on the investigators’ experience is part of the package of documents, so the experience must be confirmed before the application is filed.
How Roszdravnadzor reviews safety reports
The expert organization reviews a DSUR within 60 working days. If a report does not meet the requirements of Decision No. 79 for DSURs, Roszdravnadzor notifies the legal entity in its AIS personal account, and the legal entity has 30 working days to revise the report. After three consecutive non-compliances for one product, the expert organization informs Roszdravnadzor. Roszdravnadzor then decides whether to conduct an unscheduled inspection of the pharmacovigilance system.
If the AIS is not working, reports are sent to pharm@roszdravnadzor.gov.ru, and the recommended form of a SUSAR report is given in Order No. 3518.
GCP rules as amended by Decision No. 63 of the Council of the EEC of 1 August 2025 have applied since 10 March 2026 (the amendments entered into force 180 calendar days after publication on 11 September 2025). The reporting requirement does not apply to placebo, except where a causal relationship between the reaction and the placebo has been established. The period for submitting SUSAR reports starts on the date the authorization is received and ends after the last visit of the last patient in the country.
A DSUR is submitted in electronic form with text search, in Russian or English. The summary and the conclusion must be translated into Russian at once, and the sponsor submits the translation of the other sections within 30 calendar days on request.
How clinical practice inspections are conducted
In addition to its control over medical institutions, since 28 August 2026 Roszdravnadzor organizes clinical practice inspections at sponsors. The basis is Resolution of the Government of the Russian Federation No. 1028 of 19 August 2026, which supplemented Resolution No. 353 of 12 March 2022 (on the specifics of permitting activity) with provisions on inspections. These provisions apply until 31 December 2029. The inspection is conducted by an institution subordinate to Roszdravnadzor, and the sponsor bears the costs.
A scheduled inspection is conducted within 3 years of the registration of the product, a repeat inspection within 3 years after the scheduled one (if non-compliances were found), and an unscheduled inspection within 3 months after Roszdravnadzor’s demand. Grounds for an unscheduled inspection include, for example, information on possible falsification of trial data or on violations found when analyzing DSURs and SUSAR reports.
The sponsor files the application for an unscheduled inspection within 30 calendar days of receiving the demand. If the sponsor disagrees with the results, the complaint must be filed within 5 working days of receiving the inspection report, and it is reviewed within 30 calendar days.
What is needed to import and export biological materials
During a trial, biological materials may be collected from patients for study in Russia and abroad. The procedure for importing and exporting these materials was approved by Resolution of the Government of the Russian Federation No. 363 of 14 March 2022. A conclusion (permit) of the Ministry of Health is required for import and export.
The application is submitted with a UKEP through the State Register of Medicines (GRLS), the Unified Portal, or the «Odno Okno» («Single Window») information system. The Ministry of Health checks the documents and the presence of the CT authorization in the register and makes a decision within 5 working days, with no fee. The conclusion is issued for the period of the trial, and if the trial is suspended or terminated, the Ministry of Health ends its validity. The rules apply from 1 September 2022 to 1 September 2028.
The investigational product is imported under a separate permit of the Ministry of Health for each specific consignment.
What to do
Determine the type of trial and pay the state fees before filing. A standard or post-registration CT costs RUB 140,000 (135,000 and 5,000), and an international multicenter trial costs RUB 215,000 (210,000 and 5,000). Without information on payment, the Ministry of Health will refuse to conduct the reviews.
Check your package against the document list in Law No. 61-FZ as amended from 15 August 2026. Check the documents on the quality of the product and the preclinical study results that justify doses and routes of administration. Make sure that the investigators’ names, the names of organizations, and the details are written the same way in all documents, because the Ministry of Health checks the completeness and reliability of the information within 3 working days.
Prepare electronic signatures before filing. The application is signed with the applicant’s UKEP. If a representative files, issue a power of attorney in electronic form in a machine-readable format. Answers to requests are signed with a UKEP, so check that the certificate remains valid with a margin for the 25 working days of the reviews and for possible requests.
Appoint an employee to handle requests and put the 90 working day deadline in the calendar. Requests of the Ministry of Health and the ethics council come from different bodies, so check the personal accounts every working day. Missing the deadline results in a refusal to conduct the reviews.
Draw up a calendar of obligations after the authorization is issued. Include 3 working days to notify the start of the trial, 28 working days for changes to the protocol and to the information in the authorization, 5 working days to report completion, suspension, or termination, and 12 months for the report. Add safety on a separate line: 24 hours for the investigator to report to the sponsor, 7 calendar days for a SUSAR involving death or a threat to life, 15 calendar days for the others, and 60 calendar days for the DSUR after data lock. Appoint a responsible person with access to AIS Roszdravnadzor, and include in the budget a possible GCP inspection at the sponsor’s expense.
Regulatory framework:
1. Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines»
2. Federal Law No. 324-FZ of 4 August 2026 «On Amendments to the Federal Law ‘On the Circulation of Medicines’ and Certain Legislative Acts of the Russian Federation»
3. Tax Code of the Russian Federation (Part Two) No. 117-FZ of 5 August 2000 (version of 4 August 2026)
4. Decision of the Council of the EEC No. 79 of 3 November 2016 «On Approval of the Good Clinical Practice Rules of the Eurasian Economic Union», as amended by Decision of the Council of the EEC No. 63 of 1 August 2025
5. Resolution of the Government of the Russian Federation No. 353 of 12 March 2022 (specifics of permitting activity), as amended by Resolution No. 1028 of 19 August 2026
6. Order of Roszdravnadzor No. 3518 of 17 June 2024 «On Approval of the Pharmacovigilance Procedure for Medicinal Products for Medical Use»
7. Order of the Ministry of Health of Russia No. 708n of 23 December 2024 «On Approval of the Procedure for Maintaining the Register of Issued Authorizations to Conduct Clinical Trials of Medicinal Products for Medical Use»
8. Resolution of the Government of the Russian Federation No. 363 of 14 March 2022 «On Approval of the Rules for Importing into the Russian Federation and Exporting from the Russian Federation Biological Materials Obtained During a Clinical Trial of a Medicinal Product for Medical Use»