TheraTalks Episode 3 Explores the Future of Regulatory Harmonization, Convergence and Reliance in Latin America
August 4th, 2026 – Thera Health Policy & Access is pleased to announce the release of Episode 3 of TheraTalks, the interview series dedicated to engaging healthcare leaders, policy experts, regulators, and industry innovators in meaningful conversations about the issues shaping the future of healthcare in Latin America and beyond.
This latest episode features a conversation between José Luis Cárdenas Tomažič, Founder & Managing Director of Thera Health Policy & Access, and Rivelino Flores, Director of Regulatory Affairs & Innovation at CANIFARMA (Mexico) and one of Latin America’s leading experts in regulatory harmonization, regulatory convergence, and reliance.
During the interview, José Luis and Rivelino examine how greater regulatory cooperation can help healthcare systems improve access to medicines and medical devices, optimize regulatory resources, and create more attractive environments for pharmaceutical innovation and investment. The discussion provides an in-depth analysis of the progress achieved across the region, the practical implementation of reliance models, and the opportunities for deeper collaboration among regulatory authorities.
A central theme of the conversation is the distinction between regulatory harmonization, regulatory convergence, and reliance. While harmonization seeks to align regulatory frameworks across countries, convergence focuses on progressively adopting common international standards, and reliance allows authorities to leverage the assessments and decisions of trusted reference agencies to improve efficiency and accelerate regulatory processes.
The episode also explores the growing participation of Latin American regulatory agencies in international initiatives such as the International Council for Harmonisation (ICH), the International Medical Device Regulators Forum (IMDRF), and the Pan American Network for Drug Regulatory Harmonization (PARF), highlighting how these platforms are supporting the adoption of global best practices and fostering greater regional integration.
In addition, the discussion addresses the lessons learned during the COVID-19 pandemic, when regulatory collaboration played a critical role in facilitating timely access to vaccines and medical products. The speakers emphasize how continued cooperation can strengthen public health systems, reduce duplication of effort, and support more efficient regulatory decision-making throughout the region.
Looking ahead, Rivelino Flores shares his perspective on the future of regulatory cooperation in Latin America, pointing to the expansion of reliance-based approaches, stronger regional networks, parallel review mechanisms, and renewed opportunities for collaboration among countries, including within the Pacific Alliance framework.
“Regulatory convergence and reliance are not only technical regulatory tools; they are strategic instruments that can improve patient access, strengthen healthcare systems, and enhance the competitiveness of countries in the global life sciences ecosystem”, said José Luis Cárdenas Tomažič.
Watch the full interview here:
Watch TheraTalks Episode 3
About the Guest
Rivelino Flores serves as Director of Regulatory Affairs & Innovation at CANIFARMA, Mexico’s National Chamber of the Pharmaceutical Industry. He is widely recognized for his leadership and expertise in regulatory policy, international regulatory cooperation, convergence initiatives, and reliance frameworks, contributing actively to discussions aimed at strengthening regulatory systems across Latin America.
About Thera Health Policy & Access
Thera Health Policy & Access is a specialized consultancy and Think & Do Tank focused on health policy, market access, healthcare regulation, public affairs, and strategic intelligence. Through evidence-based analysis and stakeholder engagement, Thera supports organizations in navigating complex healthcare environments and advancing sustainable health system transformation across Latin America.
