The DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This article, first published in the September 2023 edition of DIA’s Global Forum magazine and written by ANVISA’s Antonio Barra Torres, Patricia Oliveira Pereira Tagliari, and Leonardo Dutra Rosa, summarizes session highlights with a focus on ANVISA’s short- and midterm priorities, including its objective of being internationally recognized as a reference agency.
ANVISA’s International Presence
It is widely recognized that in a global environment no single regulator can perform all its tasks alone, or establish national regulations completely disconnected from the work of other regulators. Since its inception in 1999, ANVISA has prioritized engagement in international initiatives for regulatory convergence at the regional and global levels. This participation seeks to ensure that Brazil maintains a modern, up-to-date national regulatory framework and that the Brazilian perspective is considered in the development of international guidelines and reference documents which will guide product regulation around the world. Aligned with Brazil’s historical diplomatic trajectory of promoting multilateralism and dialogue, and representing a population of more than 200 million citizens, by far the largest in Latin America, ANVISA has a long tradition as a supporter and provider of formal and informal international cooperation initiatives and agreements aimed at promoting information sharing and capacity building among regulators of all levels of maturity.
A Reference for the Region
The diversity of the region translates into significant differences in economic development and consequently regulatory capabilities between countries in Latin America. The Brazilian agency is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. Alongside its NRAr peers from Argentina, Canada, Chile, Colombia, Cuba, Mexico, and the US, and in close collaboration with PAHO, ANVISA has worked for more than a decade on activities prioritized by countries in the Americas for strengthening regulatory capacity and capabilities in the region, fostering better regulatory practices, and increasing cooperation. This cooperation entered a new phase after the COVID-19 health emergency, as one clear lesson learned from the pandemic is the value of regulators working together to find common solutions for shared challenges.
ANVISA’s current collaborations with their regional partners, especially with other NRArs from Latin America, promote and increase convergence of regulations in the region towards internationally recognized standards and guidelines such as technical documents from the International Council for Harmonisation (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the International Medical Device Regulators Forum (IMDRF), and the World Health Organization (WHO).