The Teva api Digital CADIFA Tool
Get to know the new regulations for post-approval variations
In August 2020, new landmark regulations referring to active pharmaceutical ingredients (APIs) came into effect in Brazil. In August 2023, the new regulations will be enforced, and any company wanting to register its drug products, or make changes to existing drug products, in Brazil, will have to first obtain a CADIFA.
A CADIFA is a letter from ANVISA (the Health Regulatory Agency of Brazil) showing that a certain DMF was evaluated by them and considered to be approved.
What does this mean for you, as a pharma company?
It means that if you are dealing with a post-approval variation for an existing drug product you have in Brazil, you might need to obtain a CADIFA for it.
How to know if you need a CADIFA?
This new DIGITAL CADIFA TOOL simplifies all the new regulations for post-approval variations and will show you exactly what needs to be done. It’s intuitive, easy to use, and will help you assess TODAY the changes you need to make to your drug products.