Banca de DEFESA: MAYARA GOMES OLIVEIRA

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : MAYARA GOMES OLIVEIRA
DATE: 20/03/2026
TIME: 14:00
LOCAL: Sala Laerte Grisi
TITLE:

Analysis of the regulatory framework and the current landscape of the registration process for veterinary pharmaceutical products in Brazil.

KEY WORDS:

Registration of veterinary products; Pharmaceutical veterinary products; Animal health; MAPA; BI dashboard; Data analysis; One Health.

PAGES: 101
BIG AREA: Ciências Agrárias
AREA: Medicina Veterinária
SUMMARY:

Animal health encompasses the management, prevention, and control of diseases, ensuring both sanitary safety and the health of companion and production animals. Veterinary pharmaceutical products are essential tools for promoting health, including the prevention, diagnosis, cure, or treatment of diseases affecting these animals. In Brazil, the Ministry of Agriculture and Livestock (MAPA) is responsible for the registration and inspection of products and manufacturing establishments. This research aimed to understand the scenario of veterinary pharmaceutical product registrations in Brazil by analyzing the technical and regulatory requirements involved in this process, as well as the procedures related to the granting and cancellation of registrations and the suspension of product manufacturing and commercialization. It also sought to analyze the impacts of regulatory updates on the landscape of registered products. The study was conducted using a qualitative approach, complemented by quantitative and descriptive data analysis, with the objective of understanding the current regulatory process for the registration of veterinary pharmaceutical products in Brazil and relating the regulatory framework to the information available in the Ministry’s Business Intelligence (BI) dashboard. A survey of the current legislation concerning the registration and inspection of veterinary pharmaceutical products in Brazil was carried out, in addition to bibliographic research. Beyond the review of regulations, an analysis of the guidelines and technical references required for the submission of registration applications was also conducted. Based on the analysis of the regulations, guidelines, and technical references for the submission of registration applications, a flowchart representing the stages of the veterinary pharmaceutical product registration process in Brazil was developed, aiming to systematize and clarify the registration process for these products. The results demonstrated that MAPA has shown institutional leadership over the years in consolidating a structured regulatory framework, with clear administrative requirements and defined stages for the granting of product registrations. The analysis of the BI dashboard, combined with the regulatory survey for the analyzed period, revealed the impact of regulatory updates on the landscape of registered veterinary pharmaceutical products. The profile of registrations showed a strong concentration of products belonging to the antiparasitic and antimicrobial classes intended for food-producing species, which are relevant to the Brazilian meat market, as well as for the most relevant companion animal species. The analysis also showed that although the regulatory system is robust, there is a need to improve the guidance documents for the submission of registration applications and to implement data quality practices within the Ministry’s data governance, so that the BI dashboard can be used as a regulatory intelligence tool and contribute to good regulatory practices.

COMMITTEE MEMBERS:
Presidente - 1700427 - YARA PELUSO CID
Externa à Instituição - DEBORA OMENA FUTURO - UFF
Externo à Instituição - DIEGO FONTANA DE ANDRADE - UFRGS
Externa à Instituição - MELINA CARDILO CAMPOS ALVES