In recent years, Brazil has seen significant growth in the production of poultry, cattle, pigs, goats, horses, fish, and also dogs and cats, significantly strengthening this economic sector.
This exponential growth fosters the development of innovations and the demand for the manufacturing and selling of veterinary products. For this to occur with excellence, Good Clinical Practices (GCP) are essential to guarantee the quality and safety of clinical studies and veterinary research, thus providing the technical basis for the registration of this category of products.
Thus, in addition to the applicable regulatory requirements, the CFMV, CONCEA, the Ministry of Agriculture and Livestock (MAPA), and other regulatory agencies have proposed establishing guidelines through the publication of Guides and Ordinances with guidelines for conducting these clinical studies, ensuring the accuracy, integrity, and correctness of the data obtained regarding the performance of safety and efficacy studies of veterinary products; however, these guidelines have not yet been published.
Although we do not yet have a specific guideline for compliance with the GCP, there are recommendations from MAPA that the studies be conducted according with the provisions of the Guides published by the “International Conference on Harmonization of Technical Requirements for Registration of Veterinary Products” – VICH and GL9/VICH (VICH Good Clinical Practice Guide), Ordinance No. 48, of May 12, 1997. For products of animal origin intended for human consumption (POA), it is necessary to evaluate the levels of residues of veterinary active ingredients in different matrices (meat, eggs, milk, honey and derivatives), to define the grace period to determine the Maximum Residue Limits (MRL) determined by the regulatory body.
The seminar on Good Clinical Practices within the scope of the Registration of Veterinary Products, held in Goiânia (October 2nd and 3rd, 2024), addressed topics such as audits, carried out on-site by MAPA, in Research Centers in Brazil and brought some relevant points for discussion, such as:
• Ethics and animal welfare;
• Criteria in choosing the location for conducting studies that are adequately equipped;
• Training of the team, since professionals involved in the research must be properly trained and qualified, ensuring that they follow the recommended practices and are up to date with current standards;
• Compliance with required documentation and licenses;
• Maintenance of detailed records of all procedures (SOP) and flows, observations, and results, which is crucial for the transparency and reproducibility of studies;
• Appropriate clinical protocol, presenting the objectives of the study and defining the conditions that must be carried out;
• Study design with scientific integrity of raw data;
• Animals with proper selection, handling, medical records, and forms correctly completed;
• Supervision and monitoring by the sponsor, since continuous monitoring of research activities is essential to ensure that good practices are being followed and to make adjustments when necessary;
• Transparency and dissemination of research results in a clear and accessible manner, bringing credibility to the final study report and addressing all relevant information supporting future registration.
In this way, even if not formalized in regulations, compliance with GCP and the presentation of correct evidence are essential for the scientific credibility of studies presented in the registration process, increasing the likelihood of approval by MAPA.
According to the Animal Health Department of the Secretariat of Agricultural Defense (DSA), during on-site audits carried out at some research centers focused on veterinary clinical studies, a series of inconsistencies were identified in the conduct and results of some studies. As a result, the DSA adopted several measures for requests for initial registration, registration changes and license renewal of veterinary products that contain clinical studies conducted in non-compliance with the relevant legislation.
Finding a veterinary research center that complies with the GCP is essential to ensure compliance in the registration of veterinary products. Therefore, the sponsoring company that is carrying out clinical studies must always look for research centers that adopt strict protocols, and qualified researchers that are always up to date with current regulations, ensuring the quality and safety of the studies and, consequently, of the commercial products.
Vigna Brasil Group has a specialized team capable of assisting you in all stages of your company’s regularization, conducting studies, and registering veterinary products. We can help you choose the best research center to conduct clinical studies, considering the specificities of your product, monitoring the trials from implementation, and analyzing the data obtained, until receiving the final report, which will support the registration of your product.
Let’s raise the standard of veterinary research in Brazil! 🐾🔬
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