Anvisa has just launched two extremely useful panels for monitoring the process of Letter of Suitability of the Active Pharmaceutical Ingredient Dossier (Cadifa). These panels will facilitate the consultation and follow-up of issued documents, bringing more transparency and efficiency to the review process: 

– Cadifa Consultation Panel: This panel allows to verify the valid version of the Cadifa, i.e., its status and whether it is suspended or revoked, in addition to important information, including the DIFA holder, active pharmaceutical ingredient (API), number and version. 

– Post-approval Variation Panel: This panel allows to check the order of distribution for revies of Cadifas linked to post-approval submissions. The search can be conducted by application number of notification or post-approval application itself, regulatory category, post-approval status, among others. With this tool, industry professionals can efficiently track the status of processes and estimated deadlines. 

This initiative is part of the modernization of the regulatory framework for APIs in Brazil, and according to Anvisa, the tools reflect the agency’s commitment to greater transparency in the drug product marketing authorization analysis flow, in compliance with the Access to Information Law (Law 12,527/2011). 

We agree and congratulate Anvisa on the development of these panels. 

The panel can be accessed using these links:  

– CADIFA panel: link  

– Post-approval panel: link