Clinical Trials, Ethics Review and RZN Permits in Russian Registration

1. Key takeaways

Devices whose trials require human participation follow the track of pp. 63–86 of Resolution No. 1684. The sequence is: submission together with a draft clinical trial plan, a first-stage expert review assessing whether human trials can proceed, a permit decision by Roszdravnadzor, then suspension of the registration procedure during the trial, an application by the sponsor to resume after the trial is completed, a second-stage review, and finally the registration decision by Roszdravnadzor. There are roughly seven administrative nodes in total, all counted in working days, and each of them can be planned and monitored on a project calendar.

The decisive practical point is that the administrative chain, taken as a whole, is short compared with the clinical work itself. Enrolment, follow-up and data verification consume months that no procedural optimisation can compress. Project management should therefore concentrate on selecting competent Russian clinical sites, keeping the trial plan realistic, and triggering the resumption application immediately after the trial ends, so that the suspended registration procedure restarts without dead time.

Ethics review runs in parallel with, not after, the administrative nodes. The ethical acceptability conclusion is a precondition for conducting the trial, and because its review window can reach 30 working days, late preparation of the ethics dossier delays the trial start even when the RZN permit is already in hand. The ethics submission and the first-stage expert review should therefore be prepared by the same team in the same period, with consistent documents, so that neither track waits for the other.

2. Legal basis

The instruments governing the clinical-trial track of state registration are summarised below.

Note: the departmental basis and document number of the ethics committee mechanism were not verified item by item against the official texts at the time of writing; this article describes the procedural steps as established by Resolution No. 1684 and Order No. 421n.

3. Expert insights

Insight 1: the first-stage review judges whether the trial may proceed, not what the results will be. The first-stage expert review, which can take up to 17 working days, evaluates whether the documents and the trial plan can support the conduct of a human trial, and issues a conclusion on precisely that question. The sponsor has 10 working days to contest that conclusion. Ignoring this objection window is a classic mistake: once the window closes, unresolved objections resurface at a stage where they can no longer be corrected, and the whole track may need to restart. Treat the first-stage conclusion as a formal checkpoint with its own deadline owners.

Insight 2: the administrative nodes are concentrated, and the trial itself is the variable. The permit is issued in about 5 working days, the start of the trial must be notified to Roszdravnadzor within 5 working days after it begins, the decision to resume registration takes about 2 working days, the second-stage review can take up to 8 working days, and the final decision about 7 working days. Added together, these remain far smaller than the time needed for clinical enrolment and follow-up. The management focus should therefore sit with the clinical sites and the enrolment pace, while the administrative deadlines are handled as fixed calendar events with named responsible persons.

Insight 3: three categories of situations do not require an RZN permit. P. 32 of Order No. 421n lists them: domestic devices registered under the special procedure of p. 24 of Resolution No. 1684; devices registered under Government Resolutions No. 430 and No. 552 of the Russian Federation (in force until January 1, 2028); and IVD devices and software. Even for these three categories, the ethics committee conclusion is still required. The exemption removes an administrative step, not the ethical obligations, and sponsors must not read it as a licence to simplify the clinical protocol.

4. Practical recommendations

1. Select Russian clinical sites from the RZN list that hold the relevant diagnostic and treatment qualifications, and prepare the ethics dossier in parallel rather than in sequence.
2. Set the application to resume registration as a project milestone and submit it immediately after the trial is completed, so the procedure does not remain suspended by inaction.
3. For projects falling under the permit exemptions of p. 32, still execute the full ethics requirements and do not simplify the clinical protocol.
4. Calendar every administrative node with working-day arithmetic, from the 17-day first-stage review to the 10-day objection window, and assign a named owner to each.
5. Keep the draft trial plan aligned with the dossier claims, because the first-stage review checks exactly this consistency.

5. Verification checklist

• □ The trial ground has been confirmed and the justification archived under p. 31
• □ The ethics committee conclusion has been obtained or scheduled
• □ Whether an RZN permit for the human clinical trial is required has been confirmed
• □ The 17 working day first-stage review window and the 10 working day objection period are in the project plan
• □ The notification after trial start (5 working days) and the resumption application process have assigned owners

Regulatory information verified as of October 29, 2026.

GRZAN supports sponsors running human clinical trials within Russian device registration, from site selection and trial plan drafting to the sequencing of ethics committee submissions, RZN permit filings and the resumption of the registration procedure after trial completion. Our team manages the working-day deadlines so that no objection window or notification is missed. For support with clinical trials and registration procedures in Russia, contact us at info@grzanglobal.com.