How to register APIs in Brazil - Live Online Training

How to register APIs in Brazil - Live Online Training

Seminar Nr. 20191

All times mentioned are CET.

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Sprecher

Marieke van Dalen, Global Regulatory Specialist
Susan Swiggers, Aspen Oss, Customer & Regulatory Support Officer

Hintergrund

Since August 2020, the “CADIFA Manual of Administrative Procedures” of the Brazilian Health Regulatory Agency (Anvisa) is valid and needs to be followed for API dossiers. Now, the new version of the “CADIFA Manual” is published and available in Portuguese and in English language.1

According to the agency, the DIFA (Active Pharmaceutical Ingredient dossier) must be submitted to Anvisa by the DIFA holder to receive a CADIFA (letter of suitability of the active pharmaceutical ingredient). It shows the compliance of a DIFA with the regulatory requirements. A valid CADIFA and GMP certificate are necessary for the approval of an associated marketing authorization or post-approval change application.1

The understanding of Brazilian Registration Procedures for APIs is thus important to know. This Live Online Training provides an overview of the regulatory and GMP requirements for registering APIs in Brazil and obtaining the Brazilian GMP certificate.
 
1 Source: CADIFA Manual for Administrative Procedures, CADIFA Manual nº 01, 2nd Version

Zielgruppe

This Live Online Training has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.

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Programm

How to Handle Brazilian Registrations
  • Different ways of submitting API Information
  • Procedural aspects
  • Guidelines
Content of the Registration File
  • The CADIFA System
  • The DIFA (API dossier)
  • What is different from other regions?
Handling Changes in Brazil
  • Relevant guidelines
  • How does it work in practice
Obtaining the Brazilian GMP Certificate
  • Starting the GMP certificate procedure
  • Different sites & different classes of products

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