On September 4, 2025, the Ministry of Agriculture and Livestock (MAPA), through the Coordination for the Registration of Veterinary Products (CORPV/CGIPE/DSA/SDA), issued Circular Letter No. 14/2025, establishing guidelines for demonstrating therapeutic equivalence between reference veterinary medicines and generic or similar products.

The measure aims to streamline the registration process for veterinary products, reduce the use of animals in research, and align Brazilian regulation with international technical references, such as those of ANVISA, FDA, and VICH. Key measures include:

• Substitution of clinical studies with pharmaceutical equivalence assays: MAPA now allows the use of pharmaceutical equivalence assays instead of clinical efficacy and safety studies, whenever there is a reference from another internationally recognized regulatory agency (such as ANVISA, FDA, or VICH) supporting the waiver of bioequivalence studies.
• Application procedure: Companies interested in registering veterinary products potentially eligible for biowaiver criteria must submit a SEI process under the type “VETERINARY PRODUCTS – REFERENCE MEDICINE INDICATION”, providing a technical rationale that includes, among others:
  • Pharmaceutical form;
  • Brazilian (or International) Nonproprietary Name of the API and its concentration;
  • Target species;
  • Indication of a laboratory with metrological recognition qualified to perform the required assays.
• Publication of a reference product list: MAPA will publish on its website a list of reference medicines based on submitted studies, including data such as product name, registration number, API, composition, target species, dosage form, and qualified laboratory.
• Changes and renewals of registration: Registration changes requiring new efficacy and safety studies may be supported by pharmaceutical equivalence assays, provided they are technically justified and backed by international references.
• Waiver of residue depletion studies: Such studies may be waived based on internationally accepted references and comparative analysis between formulations, subject to prior consultation with CORPV.
• Review of ongoing processes: Registration or amendment applications already filed may be revised, provided they meet the new pharmaceutical equivalence criteria, by submitting a request through the SIPEAGRO system.

The publication of Circular Letter No. 14/2025 marks a step forward in modernizing the regulation of veterinary medicines in Brazil, by incorporating international technical standards and reinforcing the 3Rs principle (Reduction, Refinement, and Replacement) in animal research.

This new guidance is expected to reduce development costs and timelines, while strengthening legal certainty and regulatory predictability for manufacturers and importers of veterinary products.

Our firm closely monitors regulatory developments in the sector and remains available to assist with clarifications, registration strategy alignment, and technical assessment of eligibility under MAPA’s new criteria.

To access the Portuguese version of the Circular Letter, click here