Uruguay is taking a crucial step toward enhancing its healthcare system by establishing its first independent regulatory agency for medicines and medical devices. This initiative, aimed at streamlining the approval and supervision of drugs, seeks to make treatments more accessible and affordable for the entire population.
The project, led by Health Minister Cristina Lustenberg, has the support of the Pan American Health Organization (PAHO), which participated in a July 2025 meeting with around 80 stakeholders from Uruguay’s healthcare sector. The minister described the current prices of some medicines and medical procedures as ‘unacceptable’ and emphasized that the autonomous agency will help change this reality.
The future agency will take over the responsibilities currently held by Uruguay’s Ministry of Public Health (Ministerio de Salud Pública, MSP), but with greater autonomy to issue licenses, monitor quality, track adverse effects, and regulate prices. This shift is expected to reduce bureaucracy and speed up access to medications. The MSP is the government body responsible for setting public health policies and strategies to improve the nation’s health outcomes.
Uruguay has also recently adopted the international Common Technical Document (CTD) format for pharmaceutical registrations, aligning itself with global standards such as those of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
The MSP has assigned a working group to plan the new agency. The Faculty of Chemistry at the University of the Republic drafted a 40-page proposal, which has already been submitted. Though the project is still in its early stages and has not yet been officially announced by the government.
According to the proposal, the new agency will be named the Agency for the Evaluation, Regulation, and Surveillance of Health Technologies (Agencia de Evaluación, Regulación y Vigilancia de Tecnologías en Salud, AUVISA). It will be linked to the MSP but operate autonomously, free from political or financial interference. After an initial state investment, the agency is expected to become self-funded through user fees and taxes on exports and sales. AUVISA will be integrated into the five-year budget as a non-state public entity. AUVISA’s estimated annual budget for salaries would be US$13 million for 250 employees.
Under current legislation, the autonomous agency will have the potential to:
- Reduce administrative delays and burdens by implementing streamlined processes and recognizing approvals from other trusted regulatory bodies.
- Enhance pharmacovigilance effectiveness through digital platforms that improve adverse reaction reporting and monitoring.
- Increase transparency in health technology assessments, complementing the work of Uruguay’s Health Technology Assessment Agency (AETSU).
Stabilizing the regulatory system will bring direct benefits to both patients and the pharmaceutical sector.
Uruguay is currently the only country in Latin America without an independent drug regulatory body, placing it at a disadvantage compared to other nations in the region that already have specialised regulatory frameworks.
Uruguay stands on the brink of a regulatory shift that could mark a turning point in its healthcare system and its integration into the regional landscape. The proposed regulatory agency represents a commitment to safer, more efficient, and better-coordinated drug management. If implemented, this move would modernize Uruguay’s healthcare system, promote a higher-quality and more competitive pharmaceutical market, and align the country with global standards.
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