Brazil

The European Commission, European Medicines Agency (EMA) and the Brazilian Health Regulatory Agency (ANVISA) have a confidentiality arrangement in place since 2021, allowing the exchange of confidential information as part of their regulatory and scientific processes.

Confidentiality arrangement

The European Commission, EMA and ANVISA signed a confidentiality arrangement in 2021. It is valid for an indefinite period of time, unless terminated by either party:

Working arrangement between EMA, Directorate-General Health and Food Safety (DG SANTE) and the Brazilian Health Regulatory Agency (ANVISA) for the exchange of non-public information on medical/medicinal products

The confidential information that EMA and ANVISA can share includes:

• applications for scientific advice, orphan designation, marketing authorisation and post-authorisation variations;
• applications for agreement of paediatric investigation plans;
• good clinical practice (GCP) inspections for specific products and GCP inspection reports available to EMA or the European Commission;
• good manufacturing practice (GMP) inspections;
• audits of manufacturers and conformity assessment bodies;
• pharmacovigilance data, particularly in relation to adverse drug reactions, as well as safety concerns arising from periodic safety update reports, post-authorisation obligations and commitments, and inspection reports;
• all legislation and guidance documents;
• information technology systems supporting regulatory processes.