Health regulatory authorities in the European Union (EU) and Brazil entered a partnership to ensure mutual recognition and regulatory harmonization to improve human and animal health.
As part of the partnership, the European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE), and their Brazilian counterpart, Agência Nacional de Vigilância Sanitária (ANVISA), have signed a confidentiality arrangement, which came into effect on 26 March 2021 and is valid for an indefinite period of time and does not require a renewal.
This allows the two authorities to exchange sensitive information about medical and medicinal products. For example, the EU and Brazil can now exchange confidential information on the safety, quality and efficacy of both human and veterinary medicines that are authorized or under evaluation, together with information on inspections, regulatory guidance and legislation. It now provides the framework under which EU and Brazilian health regulatory authorities will develop their regulatory cooperation.
It is hoped that this confidentiality arrangement will facilitate timely information exchanges on fast emerging health issues. It is likely to have a global impact on issues such as shortages of medicines, quality concerns or safety questions. Similar arrangements already in existence have proved to be vital in enabling global cooperation, particularly at times of severe crisis such as with the COVID-19 pandemic.
The EU health regulatory authority has entered into mutual recognition agreement for good manufacturing practices (GMP) inspections. Back in January 2020, the US Food and Drug Administration and EMA have signed a historic mutual recognition agreement which means the US will now recognize the GMP inspections of all EU Member States, and vice versa [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. US and EU sign milestone mutual recognition agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Policies-Legislation/US-and-EU-sign-milestone-mutual-recognition-agreement
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