Our eBook on the “Brazilian Regulatory Framework for Rare Diseases” is an essential guide to Brazil’s healthcare system, providing a comprehensive analysis of the regulatory processes related to rare disease medications, including gene and cell therapies.

The publication can be useful for anyone who needs a better understanding of the regulatory landscape on the subject in Brazil, whether a healthcare professional, policy maker, or biotechnology analyst.

Here is a preview of the content:

  • Legal definition: Learn how Brazil officially defines a rare disease.
  • Key Brazilian health authorities: Understand the roles of major entities in the pre-market phase for rare disease drugs.
  • From research to the patient: Explore the main steps in the journey of a rare disease drug – from research and development to reaching the patient.
  • Drug marketing authorization: Find out how a drug gets marketing authorization in Brazil, and learn about the priority review process for drugs indicated for rare diseases.
  • Drug incorporation into the SUS: Understand what it means for a drug to be incorporated into Brazil’s Unified Health System (SUS) and the role of the Ministry of Health in public procurements.
  • Brazilian government drug purchases: Find out how the Brazilian government procures drugs, including the bidding process and direct procurement exceptions.
  • Foreign biotech companies: Learn the necessary steps for a foreign biotech company to introduce their drug into the SUS.