Costanza Vignoli -

The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) signed a confidentiality agreement, which came into effect on 26 March 2021, with the Brazilian Authority Agência Nacional de Vigilância Sanitária (ANVISA).

This represents a first step towards a mutual agreement between EU and Brasil, which both recognized the necessity of a regulatory harmonization to improve the human and animal health.

The Authorities are indeed exchanging information concerning 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.

Regulatory Pharma Net is available to provide additional insight and updates on the agreement status.

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