Russia Updates Veterinary Clinical Trial Rules. Ministry of Agriculture Order No. 153 in Force
A veterinary drug has been on the market for a year. Clinics are sending occasional complaints about an atypical reaction in one dog breed, and the registration dossier says nothing about this risk. The developer faces a choice: expand indications and adjust dosages without evidence, or launch a new clinical study. From September 1, 2025, that decision has to be made under new rules.
Order No. 153 of the Russian Ministry of Agriculture, dated March 14, 2025, replaced the framework that had governed the industry since 2018 and shifted the underlying logic of oversight. Previously, the regulator focused on the finished clinical study report. Now the focus moves to the data collection process at every stage, with personal accountability for every entry.
How It Worked Before
From 2018, preclinical and clinical studies of veterinary medicinal products in Russia were conducted under the rules established by Ministry of Agriculture Order No. 101, dated March 6, 2018. That document set general requirements: a study plan, protocols, and a final report. It contained no detailed regulation of record-keeping, individual researcher accountability, or species-specific requirements.
The foundational principles are established not by the ministerial order but by Federal Law No. 61-FZ of April 12, 2010, On the Circulation of Medicinal Products (hereinafter — Federal Law No. 61-FZ), with the order detailing the procedure. Article 12 of the law specifies that clinical studies of veterinary medicinal products are conducted at veterinary organisations and at organisations engaged in the breeding, raising, and keeping of animals.
The law defines the objectives of such studies with equal clarity: establishing tolerability in healthy animals, determining optimal dosages, confirming safety and efficacy in specific diseases, and investigating the potential for expanded indications and previously unknown adverse effects.
The fourth objective directly serves post-marketing control. Repeat clinical studies conducted after a product reaches the market give the developer grounds to amend the label, adjust dosages for specific breeds or age groups, and formally recognise new adverse reactions.
What Changed
Order No. 153 of the Ministry of Agriculture, dated March 14, 2025, was registered with the Ministry of Justice on April 30, 2025, under registration number 82039. The full title of the document covers all three types of studies: preclinical study of a veterinary medicinal substance, clinical study of a veterinary medicinal product, and bioequivalence study. The document came into force on September 1, 2025, and will remain in effect until September 1, 2031. Order No. 101 of 2018 was declared void.
The transitional provisions follow a temporal logic: the new rules apply to studies whose plans were approved by the developer after the order entered into force. If a study plan was approved before September 1, 2025, that study may be completed under the old rules.
| Parameter | Order No. 101 (until 01.09.2025) | Order No. 153 (from 01.09.2025) |
|---|---|---|
| Status | Declared void | In effect until 01.09.2031 |
| Ministry of Justice reg. number | No. 51296, dated 05.06.2018 | No. 82039, dated 30.04.2025 |
| Application to studies | By date of conduct | By date of plan approval by developer |
| Use of third-party organisations | Permitted | Permitted with adequate facilities and qualified specialists |
The underlying logic of conducting studies has not changed: preclinical studies, clinical studies, and bioequivalence studies are still conducted according to a developer-approved plan, with protocols and final reports. Order No. 153 explicitly requires that persons responsible for conducting studies be briefed in advance on the results of prior studies involving the same product. This requirement closes the gap where a researcher might repeat known errors or overlook previously identified risks.
For post-marketing control, the change in rules means that any new study initiated after September 1, 2025 — for example, to adjust a dosage based on pharmacovigilance signals — must be planned from the outset under the updated document.
The Regulatory Path to Conducting a Study
A veterinary drug clinical study is launched through a notification mechanism, without obtaining a separate authorisation. The developer approves the study plan independently and is then required to notify Rosselkhoznadzor of the start date and location of the study within 10 working days of plan approval. The notification is submitted electronically or on paper.
Upon receiving the notification, Rosselkhoznadzor must confirm receipt to the developer within 10 working days. The regulator then engages at the regional level: within 3 working days of the notification, Rosselkhoznadzor informs the competent veterinary authority of the Russian Federation constituent entity where the study is actually being conducted. This chain ensures on-the-ground oversight without issuing a separate authorisation document for each study.
If the study poses a threat to the health of animals or people, or a risk of environmental contamination, the developer is required to suspend it. The developer must notify Rosselkhoznadzor of the suspension or resumption no later than 5 working days from the decision. Resumption is only permitted after confirming that the use of the investigational product no longer poses such a threat.
What Goes Into the Final Documentation Package
The results of a clinical study become part of the registration dossier for a veterinary medicinal product. The composition of the dossier is established by Article 17 of Federal Law No. 61-FZ and detailed in Ministry of Agriculture Order No. 648, dated July 27, 2023, on the procedure for forming a registration dossier.
The mandatory elements directly linked to clinical studies include:
a preclinical study report describing methods for determining residual quantities of the active substance in products of animal origin;
a clinical study report for the medicinal product, prepared separately for each animal species listed in the product label;
conclusions on the safety, quality, and efficacy of the product, including withdrawal periods and a safety assessment of products of animal origin.
The clinical study report must be signed by the head of the developer organisation. For medicinal products intended for companion animals that are already registered for human use, the law allows an expedited procedure: instead of a separate preclinical study report, the developer may submit the preclinical study results for the corresponding human medicinal product, and instead of a clinical study report — a literature review of clinical study results in the animal species for which the veterinary product is intended.
Owner Consent in Post-Marketing Studies
Post-marketing clinical studies of veterinary medicinal products are often conducted on veterinary clinic patients — animals with a specific owner. These studies have a distinct legal feature. Federal Law No. 61-FZ directly regulates a comparable institution for human medicinal products: clause 49 of Article 4 defines the patient information sheet as a document containing written voluntary consent to participate in a clinical study, executed after familiarisation with the study’s particulars. No equivalent statutory norm exists for animal owners under Federal Law No. 61-FZ.
In practice, this does not exempt the developer from obtaining consent. Good Clinical Practice (GCP) principles, which guide the industry when working with owned animals, require voluntary informed consent from the owner before the animal is enrolled in the study — just as in the case of a human patient. The difference is that for veterinary medicine, this principle is established by industry practice and the internal procedures of study organisations, without a dedicated article in federal law.
For the developer, this means that the owner consent form must be developed independently as part of the study organisation’s SOPs, without a ready-made statutory template. The form should include a clear description of the procedures and the investigational product, information on possible risks and adverse reactions, contact details for the responsible investigator, and an explicit statement that the owner may withdraw consent at any stage.
What to Do
Check the date of study plan approval. If the plan was approved before September 1, 2025, the study may be completed under Order No. 101. For all new projects, use Order No. 153 only.
Set up a Rosselkhoznadzor notification procedure. Record in your internal SOP the 10-working-day deadline from plan approval to submission of notification on the start date and study location. Assign a responsible person to track the deadline and document receipt of Rosselkhoznadzor’s confirmation.
Update the researcher briefing procedure. Establish a process under which each specialist responsible for a preclinical or clinical study confirms in writing that they have reviewed the results of prior studies on the product before starting work.
Prepare an emergency response procedure. Document the internal steps for cases where a threat to animal or human health is identified during a study: who decides to suspend, who prepares the Rosselkhoznadzor notification within 5 working days.
Link the study plan to post-marketing monitoring objectives. When planning a repeat study, explicitly state which of the four objectives under Article 12 of Federal Law No. 61-FZ it addresses: tolerability, dosages, safety/efficacy, or expanded indications and adverse effect detection. This simplifies the final dossier process.
Assemble the final documentation package per Order No. 648. Prepare the clinical study report separately for each animal species listed in the label, signed by the developer’s head, so the materials are ready for dossier submission without rework.
Develop an owner consent form as a standalone SOP. Since no statutory template exists for veterinary medicine, include a description of procedures, risks, investigator contact details, and the owner’s right to withdraw consent, and approve the form as a standard operating procedure before launching any post-marketing study on clinic patients.
Post-marketing clinical studies remain the primary tool for veterinary drug developers to substantiate new safety and efficacy data for an already registered product. Order No. 153 updated the procedures without rewriting the logic: study by plan, protocol at every stage, final report with full traceability. Internal SOPs for new notification timelines and the researcher briefing requirement are what need updating before the next study begins.
Regulatory basis:
1. Federal Law No. 61-FZ of April 12, 2010, On the Circulation of Medicinal Products, Articles 4, 12, 17
2. Ministry of Agriculture of Russia Order No. 153, dated March 14, 2025 (reg. with Ministry of Justice No. 82039, dated April 30, 2025)
3. Ministry of Agriculture of Russia Order No. 101, dated March 6, 2018 (declared void from September 1, 2025)
4. Ministry of Agriculture of Russia Order No. 648, dated July 27, 2023, on the procedure for forming the registration dossier for a veterinary medicinal product