Notícias
Anvisa implements new CADIFA model
New CADIFA layout
As part of its digital transformation, Anvisa has implemented a new model for issuing the Letter of Suitability of Active Pharmaceutical Ingredient Dossier (CADIFA). This step has migrated to a new system and now features a refreshed layout and new functionalities designed to make the process faster, safer and more standardized.
With this modernization, most of CADIFA information is now filled in automatically, shortening the time required for issuance and reducing the likelihood of errors. The change is part of the Agency's ongoing efforts to improve internal flows, increase administrative efficiency and strengthen its digital transformation strategy.
Anvisa emphasizes that there is no change for applicants or holders of CADIFA, nor for those who use the letter of suitability in the marketing authorization or post-approval change application. This is strictly an internal improvement, related to the Agency's workflow, with no regulatory or operational impact on the regulated sector. The information provided in the letter of suitability remains the same, and the CADIFA continues to be sent to its holder through an Official Letter in the Solicita system.
Main changes
- Updated header and overall layout aligned with Anvisa's current visual identity.
- Relocation of the signature from its previous position before the "Declaration of Access" to the end of the Letter, after "Annex 1", which contains the Active Pharmaceutical Ingredient (API) specification.
The updates are expected to contribute to greater standardization, transparency and efficacy in document management, reinforcing the Agency's commitment to continuous innovation and modernization of its services.