ANVISA and Danish Medicines Agency renew health regulatory collaboration

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ANVISA and Danish Medicines Agency renew health regulatory collaboration

Home/Policies & Legislation | Posted 06/05/2025 0 Post your comment

ANVISA, Brazil’s Health Regulatory Agency, and the Danish Medicines Agency (DKMA) have renewed their collaboration for another three years (April 2025–March 2028). This partnership, established in 2016, aims to enhance public health and regulatory practices through knowledge exchange and joint initiatives.

In March 2021, Health regulatory authorities in the European Union (EU) and Brazil formed a partnership to promote mutual recognition and regulatory harmonization, improving human and animal health. This partnership provided the framework under which EU and Brazilian health regulatory authorities will develop their regulatory cooperation [1].

The collaborations between ANVISA and DKMA spans key areas like clinical practice inspections, medical devices, artificial intelligence in regulation, and antimicrobial resistance. The next phase will expand on these priorities, ensuring both agencies remain at the forefront of regulatory innovation.

Moving forward, ANVISA and DKMA plan to enhance their technical exchanges through joint workshops, expert visits, and collaborative research. These efforts will focus on advancing the regulation of emerging health technologies, improving the quality and safety of medical devices, and integrating artificial intelligence intoregulatory processes. By deepening their partnership, both agencies seek to strengthen their regulatory frameworks and better address evolving public health challenges.

Such international cooperation is vital for addressing global health issues, aligning regulatory standards, and enhancing response capabilities. This renewed agreement underscores the importance of cross-border collaboration in building a safer and healthier future.

Strategic plans of ANVISA and COFEPRIS to advance health regulation

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EU and Brazil health authorities enter partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 6]. Available from: www.gabionline.net/policies-legislation/EU-and-Brazil-health-authorities-enter-partnership

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