Order No. 153 of the Ministry of Agriculture validating the Rules for conducting pre-clinical studies of medicinal products for veterinary use, clinical studies of medicinal products for veterinary use, and bioequivalence studies of medicinal products for veterinary use.

The document primarily addresses the regulatory framework governing preclinical, clinical, and bioequivalence studies of veterinary medicines. Its objectives include formalizing procedures for research approval, documentation, and reporting, with an emphasis on ensuring safety, efficacy, and compliance in veterinary drug development. The text explicitly references principles of study independence, data integrity, and the use of standardized protocols, aligning with overarching policy goals of veterinary medicine regulation and public health protection. Key measures outlined involve the requirement for developers to prepare detailed study plans, maintain comprehensive records (both electronic and paper), and submit reports at various stages of research. Specific procedural mandates include the use of validated measurement tools, proper storage and handling of samples, and adherence to approved study protocols. The document stipulates timelines for notification and reporting to authorities such as the Federal Veterinary and Phytosanitary Surveillance Service, emphasizing transparency and traceability. It also delineates responsibilities among research organizations, developers, and external entities involved in the research process, highlighting compliance and documentation standards. Implementation mechanisms include the approval and signing of study plans, ongoing monitoring of research conduct, and detailed reporting requirements upon study completion. The regulation underscores the importance of maintaining data integrity, procedural consistency, and stakeholder communication throughout the research lifecycle. These provisions aim to ensure rigorous oversight, enforce compliance, and facilitate the integration of research outcomes into the regulatory approval process for veterinary medicines.