Table 2 Registration process of ANVISA vs. FDA
From: ANVISA: an introduction to a new regulatory agency with many challenges
| ANVISA | FDA |
|---|---|
|
1. Pre-registration a. Protocol for clinical study | Investigational New Drug (IND) |
|
2. Registration a. Documents to be submitted b. Protocol for the new drug c. Protocol for import of the new drug | New Drug Application (NDA)/Biologics License Application (BLA) |
|
3. Post-registration a. Change in registration, renewal of registration b. History of Product Change (HMP) |
a. Supplementary NDA/BLA b. Annual Report NDA/BLA |