Buenos Aires, February 20, 2025 (PAHO). The representative of the Pan American Health Organization (PAHO), Eva Jané Llopis, and the Minister of Health of Argentina, Mario Lugones, concluded today the working sessions of national regulatory agencies from Argentina, Brazil, Chile, Colombia, Cuba, and Mexico. These agencies gathered in Buenos Aires to strengthen their internal development plans and collaboratively address cross-cutting regulatory challenges.
"Strengthening regulatory systems is a public health priority for the countries of the Region of the Americas, as these systems are responsible for overseeing and monitoring the research, production, commercialization, and use of medicines and other health technologies. Moreover, their work ensures compliance with standards of efficacy, safety, and quality, as well as equitable access," said Jané Llopis.
The PAHO representative in Argentina highlighted the efforts of participants from the six authorities of regional reference, who spent three days establishing working groups to share valuable knowledge and analyze opportunities for improvement in areas such as coordination and communication with other institutions, availability of public information, performance indicators, and interlaboratory studies.
During his address, Minister Lugones emphasized the role of national regulatory authorities in ensuring the safety and efficacy of medicines. He expressed hope that "these meetings will be the first of many, as technology is advancing rapidly, requiring agencies to find new ways to evaluate and regulate these developments."
As a key outcome of these sessions, a roadmap was developed to outline the expected short- and medium-term results based on the countries' needs.
During the opening session last Tuesday, PAHO’s Health Systems and Services Advisor in Argentina, Cristóbal Cuadrado, stated: "Challenges are always easier to face together, which is why this initiative is so important—it enables us to learn from each other’s strengths, expand capabilities, and move forward to the next level."
Agustina Bisio, head of Argentina’s National Administration of Medicines, Food, and Medical Technology (ANMAT), expressed gratitude for both in-person and virtual participation. She also highlighted the privilege of having ANMAT selected as the host agency for the event. Additionally, she acknowledged PAHO’s efforts in identifying not only each agency's strengths but also opportunities for improvement.
The activity is part of the regulatory system qualification program coordinated by PAHO, aimed at facilitating cooperation mechanisms and inter-institutional recognition among national regulatory authorities (NRAs). Through this initiative, PAHO has evaluated over 75 percent of the region's regulatory systems using a standardized tool to identify the strengths and opportunities for improvement within the NRAs.
During the second half of 2024, PAHO conducted visits to NRAs of regional reference, including Argentina’s ANMAT, Brazil’s National Health Surveillance Agency (ANVISA), Cuba’s Center for State Control of Medicines, Equipment, and Medical Devices (CECMED), Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Colombia’s National Institute for Medicines and Food Surveillance (INVIMA), and Chile’s Institute of Public Health (ISP).
These visits helped identify key gaps and challenges within each agency. Additionally, the assessment confirmed the presence of certain cross-cutting regulatory gaps that could be more effectively addressed collectively by leveraging shared capacities—the primary objective of the meeting.
