Pharmacy Courses

Drug Product Registration Process in Brazil

The generic drugs market in Brazil has shown an increasing trend in recent years. While in 2016 around 12.73 percent of the total sales value of pharmaceutical products acquired through pharmacies in the South American country was attributed to generic drugs, that share increased by approximately 2.3 percentage points by 2020. That year, the market value of the Brazilian pharmaceutical industry was estimated at nearly 21 billion U.S. dollars. In 2022, the generic drug market size reached US$ 19.5 Billion in Brazil.

So, Brazil is a big market for generic drug manufacturer and evereone wan to enter this market as soon as possible. In this article we try to share a overview of generic drug registration process in Brazil.

There are three main steps of drugs registration in brazil -

Step 1: Preparation and Submission of Registration Dossier to ANVISA

Step 2: ANVISA GMP Inspection of Manufacturing Sites 

Step 3: Local testing

In Brazil the registration dossier is structured in eCTD format and it has two main parts:

Part 1- Administrative Part:

It corresponds to Module 1 and includes compilation of all administrative data and local information.

Part 2 - Technical Part:

It corresponds to Module 2, Module 3, Module 4 and Module 5 that include summaries od pre-clinical studies; CMC information; nonclinical data and reports; and clinical information and reports.

Content of Registration Dossier for Branded Generic Drug

Module 1 (Regional Admin Operation)

  • Sanitary license of local representative 
  • Local representative operating authorization
  • Registration of local Pharmacist at professional counsil
  • Petition form
  • Justification for product registration
  • Labeling of different presentations
  • Previous Communications with ANVISA
  • CPP issued from the HA in country of origin
  • GMP certificates issued from the HA in country of origin
  • GMP certificates granted by Anvisa
  • Registration status worldwide
  • Pharmacovigilance data
  • Product labeling in portuguese 
  • TSE information 

Module 3 (Quality)

  • Table of contents of Module 3
  • Body of data 
    • Drug Substance
    • Drug Product
  • Literature references used in Module 3

Module 5 (Clinical Study Reports)
  • BE Studies

Resource Person: Ananda Ferreira
Previous Post Next Post