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.
EU and Brazil health authorities enter partnership
Home/Policies & Legislation | Posted 21/05/2021 0 Post your comment
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 .
Collaboration between regulatory authorities for biosimilars
LATIN AMERICAN FORUM – Coming soon!
To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.
LATIN AMERICAN FORUM – Próximamente!
Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.
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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