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Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 
• By Francesca Bruce

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

Brazil wants to make it easier for companies to register their biological products in the country. (Shutterstock)
Key Takeaways
  • Brazil’s drug regulator, ANVISA, wants to make it easy for drug companies to register their biologics in the country and make post-registration changes.
  • It has updated guidelines on existing registration and post-registration procedures.
  • The new technical note incudes new drug registration subject codes.

ANVISA, the Brazilian’s medicines regulator, is aiming to make it easier for companies to request drug registrations for biologic products and post-registration changes.

To this end, the regulator has published technical note 51/2025, which updates registration and post-registration procedures for biological products set out in technical note 134/2024.

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