Confidentiality arrangement between EU and Brazilian regulatory authorities

News 06/05/2021

The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a PDF icon confidentiality arrangement with their Brazilian counterpart Agência Nacional de Vigilância Sanitária (ANVISA).

This new partnership between the health regulatory authorities of the EU and Brazil is an important step towards mutual recognition and regulatory harmonisation to improve human and animal health.

The arrangement allows its participants to exchange sensitive information about medical and medicinal products. This includes confidential information on the safety, quality and efficacy of both human and veterinary medicines (already authorised or under evaluation) as well as information on inspections, regulatory guidance and legislation.

Confidentiality arrangements of this type contribute to timely information exchanges on fast emerging issues with global impact such as shortages of medicines, quality concerns or safety questions and are the corner stone on global cooperation, for example in crises such as the current COVID-19 pandemic.

The confidentiality arrangement, which came into effect on 26 March 2021, is valid for an indefinite period of time and does not require a renewal. It provides the framework under which EU and Brazilian authorities will develop their regulatory cooperation.

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