MSD
atin America is at a pivotal moment in the evolution of its regulatory systems. Factors such as the adoption of emerging technologies, the urgent need to accelerate access to medicines, and the region’s increasing economic integration with the rest of the world have brought forth an inescapable question: How can we make health regulation more efficient, transparent, and sustainable?
A Region Willing to Collaborate
The session brought together representatives from the Pan American Health Organization (PAHO), the Ibero-American Medicines Authorities Network (EAMI), and the Latin American Network of the European Federation of Pharmaceutical Industries and Associations (EFPIA LatAm Network). From different perspectives—technical cooperation, institutional strengthening, and a strategic industry view—experiences and converging viewpoints were shared.
Collaborative networks enable the sharing of knowledge, capacity-building, and the promotion of harmonization, all of which have a direct impact on the quality, efficiency, and timeliness of regulatory processes. Examples such as the Pan American Network for Drug Regulatory Harmonization (PANDRH), coordinated by PAHO, and the EAMI Network have proven their ability to generate tangible and sustained results.
EAMI: A Platform for Capacity-Building and Technical Action
EAMI presented its achievements from more than 25 years of joint work, highlighting the development of regional guidance, the implementation of pharmacovigilance systems, and specialized training programs. One case in point was the FACEDRA system, the first Central American portal for reporting suspected adverse reactions to human medicines, which has received more than 25,000 notifications in the past several years.
The proposal was also made to advance pilot exercises in regulatory convergence, beginning with minor variations in products, through mutual recognition of evaluations conducted by national agencies, as a preliminary step toward more integrated procedures.
In addition to its technical achievements, the network has been recognized by regulators in the region and external partners such as the European Medicines Agency and the Council of Ministers of Health of Central America and the Dominican Republic (COMISCA) for its strong focus on regulatory capacity building, offering training programs, internships, and technical exchanges that have supported the progressive strengthening of health authorities across the region.
PANDRH: A Regional Policy Framework
PAHO shared the strategic role of the Pan American Network for Drug Regulatory Harmonization (PANDRH) as a regional policy tool endorsed by Member States. In its most recent conference, the network adopted key recommendations: strengthening regulatory frameworks, advancing reliance mechanisms, boosting regional production, improving preparedness for health emergencies, and reinforcing post-market surveillance.
PAHO also promotes the use of the WHO Global Benchmarking Tool (GBT) as a diagnostic and planning tool for institutional development, and has supported the recognition of regional reference regulatory authorities.
PANDRH is currently undergoing a strategic repositioning, with priorities that include renewing its work plan, strengthening governance, securing technical and financial sustainability, and expanding synergies with other regional and global harmonization platforms.
Industry and Trade Agreements: Opportunities for Convergence
Discussion from the EFPIA LatAm Network highlighted how trade agreements—such as the EU-Central America Association Agreement and the EU–Mercosur agreement—can serve as vehicles to promote regulatory cooperation and convergence. These instruments provide platforms to harmonize practices, establish technical dialogue mechanisms, and facilitate access to innovative health technologies.
The industry has also played a role in disseminating good practices and acting as a bridge between agencies with different levels of maturity through webinars, technical workshops, and joint advocacy initiatives.
Reliance: From Latin America to the World
Reliance was one of the most discussed topics, framed as a strategic mechanism for regulatory efficiency. Panelists noted that Latin America has been a pioneer in this area, with principles developed within the PANDRH Network since 2016 and adopted in 2018—serving as a foundation for the WHO Good Reliance Practices guidance published in 2021.
Today, countries across the region are applying reliance through WHO Collaborative Registration Procedures (CRP), the use of Certificates of Pharmaceutical Products (CPP), recognition of decisions from WHO Listed Authorities, and regional mechanisms such as the Caribbean Regulatory System (CRS).
Bridging Gaps: A Shared Responsibility
How to address regulatory asymmetries was another key discussion theme. Not all countries possess the capacities of more developed agencies, and so adapting regulatory models to the national context is essential. Tools such as the WHO Global Benchmarking Tool (GBT) and institutional development plans were cited as crucial for guiding this progressive strengthening.
Participants also emphasized the importance of avoiding duplication across networks and promoting synergy through coordinated planning and practical cooperation among multilateral organizations and national agencies.
Call to Action: From Theory to Implementation
One of the session’s key takeaways was the need to move beyond conceptual discussions and toward practical application. A regulators-only, hands-on reliance implementation workshop was announced at this Town Hall for DIA Latin America Annual Meeting 2025 to continue the active participation of regulatory agencies from across the region; participation from industry representatives will be possible, albeit limited.
In the area of regulatory convergence, panelists agreed to have follow-up conversations so as to identify specific products with divergent regulatory assessments across countries, with the goal of conducting joint reviews and generating shared insights on regulatory criteria, thus promoting technical alignment. The main idea is to run a regional pilot, which will allow greater mutual understanding among regulators, and an opportunity for technical exchange between industry and regulators.
Additionally, the importance of strengthening the use of the WHO GBT was emphasized, positioning it as a strategic instrument to guide institutional development plans and support the continuous improvement of regulatory authorities. This was indicated as yet another area of opportunity for collaboration between PAHO and the regional industry associations.
The Latin America Town Hall at DIA Europe 2025 demonstrated that the region has developed replicable models of regulatory collaboration. Networks like PANDRH and EAMI, alongside multilateral organizations and the pharmaceutical industry, have helped establish a modern framework grounded in trust, technical cooperation, and shared evidence.
The challenge now is to sustain this momentum, institutionalize best practices, and ensure that all countries are included in this process of evolution.