Employee of FGBU «VGNKI» delivered a report at the conference on poultry farming held by FGBU «VNIIZH»
On February 26, 2025, the «Federal Centre for Animal Health» (FGBI «ARRIAH») in Vladimir held the first day of the International Scientific and Practical Conference for Poultry Farms' Veterinarians from the Russian Federation and the CIS, titled «Current Challenges in Diagnosing and Preventing Infectious Poultry Diseases in Industrial Farming». Yuri Zuev, the Director of the Virology Department at «The Russian State Center for Animal Feed and Drug Standardization and Quality» («VGNKI») and the Candidate of Veterinary Sciences, attended the conference and delivered a report.
In his speech, Yuri Zuev highlighted the key aspects of the registration of immunobiological medicinal products for the prevention of viral diseases in poultry farming. He noted that modern industrial poultry farming, with its high stocking density, creates risks of mass infections that capable of causing significant economic damage. To minimize these risks, specific prophylaxis is actively used, including the mass immunization with live and inactivated vaccines. At present, a total of 179 products against viral diseases in poultry are registered within the territory of the Russian Federation, 68 of which are of domestic production and 111 are imported.
During the speech, special focus was placed on the requirements for the state registration of immunobiological medicinal products. In accordance with regulatory provisions, products that are introduced into circulation in Russia for the first time, as well as previously registered products manufactured in new pharmaceutical forms or dosages with proven clinical significance, are subject to mandatory registration. In addition, new combinations of already registered products are subject to mandatory examination.
The main part of the registration process involves preparing a draft veterinary instruction, provisions of which must be supported by preclinical and clinical trials' results. For immunobiological products, the pharmaceutical substance receives particular focus: data on the strains, including their names, molecular-genetic and biological characteristic, and depository locations, along with details on the substance's manufacturing technology and quality control methods at every manufacturing stage, are submitted during the registration process.
Yuri Zuev emphasized that the decision on the state registration is based on a product's compliance with the established requirements. Common grounds for the refusal of registration may include unproven quality and efficacy, potential harm exceeding benefits, presence of unvalidated control methods specified in regulatory documentation, non-compliance with the quality standards, insufficient data on the product stability or immunity formation and duration, late submission of the materials and components used for research, and lack of strain deposition information.
At the end of the report, a complete list of immunobiological products of domestic and foreign production intended for the prevention of viral diseases in poultry and available within the territory of the Russian Federation from 2020 to 2025 was presented.
The participation of the leading virologist of «VGNKI» in the conference underscores the important role of the Center in ensuring the quality and safety of veterinary medicinal products, as well as its contribution to the development of a scientific and practical cooperation between specialists from Russia and the CIS countries.