The Brazilian Ministry of Agriculture (MAPA) has established a new regulatory milestone with the publication of the Manual of Bioinput Methodologies. This document officially incorporates molecular techniques like genomic sequencing and qPCR into the registration process, a shift that GoGenetic is helping companies navigate through specialized technical dossiers.
Manual of Bioinput Methodologies: The New Standard for Analysis and Registration in Brazil
January 5, 2026
The Manual of Bioinput Methodologies, published by the Ministry of Agriculture and Livestock (MAPA) in 2025, establishes a new regulatory framework for the analysis and registration of biological products in Brazil. The document clearly defines which methodologies can be used, how they must be validated, and the level of documentation required for a product to be accepted.
What changes with the Manual?
One of the main advances is the definitive incorporation of molecular techniques—such as genetic sequencing and qPCR—as official tools for the identification and quantification of microorganisms. This is crucial for complex products where classical methods (like plating) fail, such as formulations with new strains, exclusive strains, or microbial mixtures.
The Manual mandates that whenever a company intends to register a product using these advanced methods, they must present a complete validation dossier. This validation cannot be generic; it must be specific to the product, the strain, and the formulation matrix.
GoGenetic has analyzed the new regulations to offer three integrated services ensuring compliance:
- Taxonomic Identification Dossier (Whole Genome): Uses Average Nucleotide Identity (ANI) and comparative phylogenomics to prove strain identity and exclusivity.
- Methodology Validation Dossier (qPCR for Identification): Validates specificity, absence of cross-reactions, sensitivity, and repeatability to ensure the method identifies only the declared strain.
- Methodology Validation Dossier (qPCR for Quantification): A critical step that focuses on viable cells. The validation ensures the method does not overestimate results by amplifying DNA from non-viable cells, a key requirement of the new Manual.
A New Regulatory Scenario
The Manual makes it clear that for bioinput registration, performing lab analysis is no longer enough. Companies must validate methodologies, document every step, and prove analytical performance. GoGenetic bridges the gap between molecular biology and regulatory requirements to help transform scientific innovation into registered, compliant biological products.
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