For the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them. MSD’s Leonardo Semprun, writing in the May 2024 edition of DIA’s Global Forum magazine, highlights his key takeaways.
Representatives from regulatory authorities and industry joined the discussions, including the Brazilian Health Regulatory Agency (ANVISA), European Medicines Agency (EMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), and an industry expert who conducted a comparative study in the area of post-approval changes, focused on the regulatory realities in Latin America.
The sophistication of emerging technologies requires more complex regulatory oversight, a challenge for most regulatory systems in Latin America.
Latin America is witnessing substantial growth in both its population and economy, leading to new challenges for regulatory authorities, industry, and other stakeholders. These challenges encompass managing the complexity and increasing volume of products that need to be regulated as well as embracing emerging technologies and responding to evolving healthcare demands.
The most important solution available to face this challenge is the adoption of reliance practices by regulators in Latin America; more specifically, unilateral reliance on trusted authorities (such as those listed by the World Health Organization). ANVISA is among the regulators in this region currently reforming its reliance framework to adapt to international best practices. The process of building the new reliance regulations in Brazil was praised by the panelists for being transparent, comprehensive, and inclusive, encompassing public consultations, open dialogue with the private sector, and benchmarking of global lessons learned. These will help optimize regulatory processes in Brazil, ensuring consistency, relevant regulatory assessments, and efficient reviews.
Learnings from collaboration with Europe has enabled progress in Latin America’s regulatory practices.
Discussions at DIA Europe reflected the consensus that Latin America has learned from the experience of sharing information with the European regulatory system. These experiences inspired and supported the development of local regulations of medical products, contributing to regulatory convergence, the progress of innovation, and better health outcomes.
One illustrative example is the ANVISA-EMA confidentiality arrangement signed in 2021, which is already delivering positive results to both agencies. Through this agreement, the Brazilian agency joined the Opening procedures at EMA to non-EU authorities (OPEN) initiative, a mechanism through which the European regulator works in a collaborative assessment with ANVISA for the registration of a Chikungunya vaccine manufactured in Brazil.
