Anvisa informs that version 01 of the Cadifa Manual for Administrative Procedures (MANUAL-F-ANVISA-01) is now available. The document was updated to forecast and detail the flows "Similar DIFA", "Use of CADIFA by another CADIFA", "Optimized analysis procedure" and "Change of CADIFA holder", in continuity with the implementation of strategies to simplify the assesment of Cadifa applications (Letter of Suitability of the Active Pharmaceutical Ingredient Dossier) as part of the implementation of the new regulatory framework for active pharmaceutical ingredients (APIs). 

The Application Form (FORM-635. MANUAL-F-ANVISA-011) and the Registry Form (FORM-634. MANUAL-F-ANVISA-011) have also been updated. The Checklist of Annex III of IN 289/2022, related to the optimized analysis procedure, and the Form for Change of the CADIFA Holder were made available.

Understand

DIFA Similar: applicable for when the DIFA holder may wish to apply for another CADIFA for the same API, either in cases when it is not possible to apply for a change or when the holder wishes to have separate CADIFAs for different conditions of manufacturing or quality attributes (for example, to cover an alternative manufacturing process, manufacturing site or an alternative grade).

Use of Cadifa by Another Cadifa: applicable for cases where a CADIFA application (secondary CADIFA) may reference another CADIFA (primary CADIFA) for your starting material or intermediate.

Optimized Analysis Procedure: established by Normative Instruction - IN No. 289/2024, is applicable to the API subject of the associated CADIFA application when the quality grade of the API is identical to that approved by the Equivalent Foreign Regulatory Authority (AREE).  

Change of the Cadifa Holder: applicable to corporate (spin-off, merger or incorporation) and commercial transactions (operation that results in the transfer of assets or a set of assets, without the occurrence of any corporate operation)  between companies that result in the need to update data related to the holder of CADIFA, applying exclusively to cases in which the conditions and technical-sanitary characteristics of the API of the CADIFA are maintained.