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Table 2 Registration process of ANVISA vs. FDA

From: ANVISA: an introduction to a new regulatory agency with many challenges

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