The Brazilian Official Gazette has published Anvisa’s Resolution No. 954, establishing new guidelines for the simplified process of drug registration, post-registration, and renewal in Brazil.

Coming into effect on January 21, 2025, the regulation introduces significant innovations and adjustments aimed at enhancing regulatory process management and sanitary control within the pharmaceutical sector.

 

What changes with Resolution No. 954?

The resolution restricts the simplified procedure to companies within the same economic group, ensuring uniformity in safety, quality, and efficacy standards between the original product and its simplified registered counterparts.

This restriction seeks to mitigate health risks identified by GGMED.


Audits and Transparency

Among its highlights, the resolution allows Anvisa to audit simplified registrations at any time.

Companies holding registrations must submit the complete dossier or parts thereof within 60 days of request.

 

Pricing and Registration Renewal

The resolution reinforces that price evaluation criteria remain unchanged, regardless of the registration pathway, as defined by CMED Resolution No. 2/2004.

Additionally, companies will have 30 days to file post-registration changes for the primary process.

 

Other Key changes

  • The primary petition must be linked to a currently valid drug registration.
  • Specific conditions were established for delinking processes from the simplified model.
  • Issues related to dual branding will be addressed in future regulatory revisions.

 

Why are these changes important?

In addition to protecting public health, these measures provide greater predictability and security for drug manufacturers—marking a significant step toward enhancing transparency and efficiency in Brazil’s regulatory processes.

Learn more about the resolution here.

 

For more information about regulatory issues in Brazil, ELS can help.

Please contact your local ELS consultant or email: info@elssolutions.pt

 

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