Russia Repealed Order No. 200n. How the EAEU Now Inspects Clinical Trials Under the New Rules
Most regulatory affairs specialists have long been accustomed to GMP inspections. Inspectors arrive, verify the manufacturing site, and issue a certificate. The system is well-established. With GCP inspections, everything was different: each country acted independently, rules varied, and the actual inspection of clinical trials was more often declared than systematically practiced.
Since September 2024, the situation has changed. Russia repealed its national order on Good Clinical Practice (GCP), the EAEU introduced unified rules for GCP inspections, and clinical trial participants are now operating under a different system. Sponsors and trial sites should understand the details before inspectors arrive.
How the National System Worked
Until September 2024, GCP in Russia was regulated by Ministry of Health Order No. 200n, adopted in 2013 based on an earlier version of the international ICH E6 guideline. GCP inspections formally existed but were conducted in a fragmented manner: each EAEU member state followed its own logic, timelines, and formats. There was no unified approach among Union regulators as to what constituted a critical finding.
In practice, this created several problems. Multi-center trials spanning multiple EAEU countries fell under different inspection standards in each of them. The results of inspections conducted in one country might not be recognised by another. If a drug was studied exclusively at foreign sites, the Russian regulator lacked a clearly defined mechanism for evaluating the rules under which those trials were conducted.
Few GCP inspections were initiated as part of registration procedures. There was no established procedure specifying when exactly to launch them, whom to inspect, or what timelines to follow for preparing reports. By that time, the FDA, EMA, and MHRA already possessed years of GCP inspection experience with clear classification of findings and well-defined consequences for registration dossiers.
What the 2024–2025 Reform Changed
On 1 September 2024, Ministry of Health Order No. 200n became null and void. It was replaced by EAEU Council Decision No. 79 dated 03.11.2016 «On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union» (hereinafter — the EAEU GCP Rules), marking a shift from national to Union-level regulation with the scope extended to all member states.
Subsequently, by EAEU Council Decision No. 66 dated 06.09.2024, separate Rules for Conducting Pharmaceutical Inspections for Compliance with the EAEU GCP Rules were incorporated into EAEU Council Decision No. 83 dated 03.11.2016 «On Approval of the Rules for Conducting Pharmaceutical Inspections» (hereinafter — Decision No. 83). A year later, by EAEU Council Decision No. 60 dated 01.08.2025, Decision No. 83 was supplemented with analogous rules for GLP inspections.
The GCP inspection system in the EAEU now has a complete regulatory foundation. There is both a standard for conducting trials (Decision No. 79) and a procedure for verifying compliance with it (Decision No. 83 in its current version).
Three Inspection Formats
Previously, only on-site inspections were conducted. The GCP Rules within Decision No. 83 provide for three formats.
An on-site inspection involves the physical presence of the inspection team at the site. A remote inspection is conducted via videoconference with remote access to the inspectee’s computerised systems. Unlike similar GMP provisions, the remote format for GCP is permitted not only in emergencies, but also based on a risk-based assessment by the inspectorate. A documentary inspection applies when a site visit is impractical: by decision of the competent authority, the review is based entirely on submitted documents.
Remote and documentary formats reduce logistics costs for inspections of foreign sites. At the same time, they require a higher level of readiness: documents must be maintained in electronic form, systems must be validated, and the audit trail must be complete at all times.
| Parameter | Before the Reform (National Level, RF) | After the Reform (Union Level, EAEU) |
|---|---|---|
| Regulatory Basis for GCP | Ministry of Health Order No. 200n | EAEU Council Decision No. 79 |
| GCP Inspection Rules | Absent at Union level | Decision No. 83 (introduced from 06.09.2024) |
| Inspection Formats | On-site only | On-site, remote, documentary |
| Inspection Team Composition | Established by national law | At least 2 inspectors |
| Inspection Report Preparation Timeline | Determined nationally | 20 working days from completion |
| Inspected Entity Response Timeline | Determined nationally | 20 working days from receipt of report |
| Response Evaluation by Inspection Team | Determined nationally | 15 working days |
When an Unscheduled Inspection is Initiated
Scheduled GCP inspections are conducted within 3 years of the drug registration date, in accordance with the Rules for Registration and Examination (EAEU Council Decision No. 78). Unscheduled inspections are initiated during the examination of the registration dossier. The timeline for an unscheduled inspection must not exceed 40 working days from the date the applicant submits the request.
The criteria for an unscheduled inspection are set out in detail in the GCP Rules of Decision No. 83. Red flags include ethical violations in handling trial subjects, statistical anomalies in data (unexplained differences between sites, abnormal patient distribution), doubts about the integrity of source documentation, and discrepancies between protocol versions and the final clinical study report. For bioequivalence (BE) studies, the list of triggers is equally detailed.
If a study was conducted exclusively outside the EAEU, this does not exempt it from a GCP inspection. The competent authority is entitled to initiate an inspection of any foreign site whose data appear in the registration dossier. If inspection results are delayed, the dossier examination is suspended. The applicant has no more than 180 working days to submit the results, after which the examination is terminated.
Classification of Non-Compliances
The GCP Rules of Decision No. 83 establish a three-tier classification of findings — broadly aligned with FDA and EMA practice, but now carrying formal status in Union law.
Critical non-compliances cover those that negatively affect the quality and integrity of data or the rights, safety, and well-being of trial subjects. This includes data manipulation, deliberate misrepresentation, and the complete absence of source documentation. The Rules are unambiguous on this point: such non-compliances are unacceptable.
Major non-compliances are not critical in nature, but can negatively affect data quality and reliability, or the rights of subjects. Examples include systematic protocol deviations, inadequate monitoring, sample storage failures, and missed timelines for reporting serious adverse events. The Rules explicitly note that a combination of minor findings can be reclassified as a major non-compliance.
Minor (other) non-compliances do not affect data or subjects but indicate areas requiring improvement.
A critical finding resulting from a GCP inspection leads to a refusal of registration or a determination that study data cannot be used. This is explicitly stated in Decision No. 78.
The Audit Trail as the Mirror of a Study
A GCP inspection today is not just a review of paper archives. Inspectors are entitled to request remote read-only access to the inspectee’s computerised systems, including electronic data capture (EDC) systems and electronic Trial Master Files (eTMF).
The audit trail (a chronological record of all actions taken on data) is one of the primary inspection targets. Backdated entries, bulk edits without justification, and mismatched timestamps all signal data integrity issues and lead to critical findings. The EAEU GCP Rules explicitly name «audit trail settings and the information captured by the audit trail» as a subject of inspection for the bioanalytical portion of studies.
The Trial Master File (TMF/eTMF) reflects the entire course of a study: if a document is absent from it, the corresponding procedure is considered not performed. In the Union system, an incomplete TMF results in a major or critical finding depending on what exactly is missing.
The Sponsor Bears Ultimate Responsibility
The GCP Rules of Decision No. 83 devote considerable attention to sponsor oversight of contract research organisations (CROs). A sponsor may delegate functions to a CRO, but retains ultimate responsibility for data quality and integrity. An inspection examines not only the CRO’s performance, but also how the sponsor documented its oversight of the contractor. The absence of documented oversight is a typical major finding.
Qualification requirements for inspectors are clearly defined in Decision No. 83: a higher education degree in medicine, pharmacy, pharmacology, toxicology, or a related field; practical inspection experience; and knowledge of Union legislation and the specifics of the relevant study types. The inspectors know the subject well.
What to Do
Assess the status of your TMF. Review the list of essential documents from Section 8 of Part II of the EAEU GCP Rules (EAEU Council Decision No. 79) for each active and completed study. A document absent from the TMF is considered not performed.
Check the audit trail in your electronic systems. Ask your IT department or validation team to confirm that all data transactions are recorded: date, time, user, and reason for change. For EDC systems this is a standard requirement; verify that settings are enabled and logs are available for export.
Update training logs. Every team member must complete protocol-specific training before performing any trial procedure — not concurrently or after the fact. Inspectors check timestamps: the training date must precede the date of the first action in the study.
Document your CRO oversight. If you work with a contract research organisation, gather evidence of active control: correspondence on identified deviations, records of co-monitoring visits, and contractor qualification assessments. A contract alone is not sufficient.
Conduct a self-inspection. Appoint an internal or external auditor to review one completed study using the EAEU GCP Rules checklist. This is the only reliable way to identify systemic weaknesses before inspectors do. The self-inspection report itself serves as evidence of quality system maturity.
The transition to the Union level means the rules are now the same for everyone: Russian, Kazakh, and Belarusian market participants, and foreign sponsors submitting studies for registration in the EAEU. The competent authorities of member states mutually recognise each other’s GCP inspection results — this is explicitly enshrined in Decision No. 83. A successful inspection of a foreign site by the Russian inspectorate will not need to be repeated by Kazakh colleagues. But only if the documentation is in order.
Regulatory Framework:
1. Decision of the Council of the Eurasian Economic Commission No. 82 dated 03.11.2016 «On Approval of General Requirements for the Quality System of Pharmaceutical Inspectorates of the Member States of the Eurasian Economic Union»
2. Decision of the Council of the Eurasian Economic Commission No. 79 dated 03.11.2016 «On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union»
3. Decision of the Council of the Eurasian Economic Commission No. 83 dated 03.11.2016 «On Approval of the Rules for Conducting Pharmaceutical Inspections» (as amended 01.08.2025, No. 60)
4. Decision of the Council of the Eurasian Economic Commission No. 78 dated 03.11.2016 «On the Rules for Registration and Examination of Medicinal Products for Medical Use»