
Overview
Annual influenza vaccination is one of the most effective strategies for preventing respiratory complications and reducing hospitalizations caused by the flu virus. Each year, the vaccine composition must be updated based on the most recent circulating strains. In 2025, ANVISA approved a new regulation defining the composition of seasonal influenza vaccines to be used in Brazil, aligning the country with World Health Organization (WHO) recommendations.
Introduction
Each year, the WHO issues guidelines on which influenza virus strains should be included in vaccines for the Southern Hemisphere. ANVISA adopts these recommendations through an official regulation, ensuring that vaccines distributed in Brazil remain effective against the currently circulating viruses.
The New Regulation:
· Defines the specific strains to be included in trivalent and quadrivalent vaccines for 2025;
· Establishes technical criteria for the manufacture, control, and release of vaccine lots;
· Provides guidance on submission deadlines and procedures for updating vaccine compositions by marketing authorization holders.
The timely approval of this regulation is crucial for ensuring the success of Brazil’s national vaccination schedule and protecting the population before seasonal peaks.
What’s New in Brazil and Regulatory Implications
With this regulation in force, marketing authorization holders must quickly update their registration dossiers and submit the necessary documentation to ANVISA. This process involves:
· Updating formulation data;
· Reviewing stability studies;
· Ensuring manufacturing timelines align with regulatory deadlines.
From a regulatory standpoint, the annual update reinforces the need for manufacturers, importers, and distributors to plan ahead and remain compliant with all applicable requirements. Failure to meet deadlines or adjust processes could impact supply and result in regulatory sanctions.
Conclusion
ANVISA’s new regulation on influenza vaccine composition reaffirms Brazil’s commitment to public health and its alignment with international regulatory standards.
GRP Brazil offers comprehensive support for updating vaccine registrations, managing technical dossiers, and navigating communication with ANVISA. Rely on our team to ensure regulatory compliance and timely market access for your immunization products.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
 Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.Â