The Regional Platform on Access and Innovation for Health Technologies (PRAIS) was a pioneering digital initiative led by the Pan American Health Organization (PAHO) to support regulatory strengthening and improve access to quality health technologies across the Americas.
Launched in 2012, PRAIS was created to address a critical regional need: fragmented regulatory information and limited mechanisms for collaboration among national authorities. It provided a shared, multilingual infrastructure where regulators, policymakers, and technical experts could access reliable information, exchange knowledge, and work together more effectively.
Over its lifecycle, PRAIS evolved into a regional digital public good designed to complement national regulatory systems while respecting their autonomy. It helped reduce information gaps, supported transparency, and enabled more consistent regulatory practices across countries.
A Trusted Regional Hub for Regulatory Systems
- Regulatory intelligence and knowledge sharing
Bringing together data, guidance, and tools to support decision-making across medicines, medical devices, and other health technologies. - Regional collaboration and communities of practice
Facilitating peer-to-peer exchange among regulators and experts through thematic networks and collaborative spaces. - Capacity strengthening and convergence
Supporting countries with different levels of regulatory maturity through shared resources, comparative tools, and learning opportunities. - Crisis response and coordination
Enabling timely information exchange and collaboration during public health emergencies, including the COVID-19 pandemic.
From Fragmentation to Regional Cooperation
Prior to PRAIS, access to regulatory functionality information on medicines and other health technologies in the Americas was highly fragmented. Regulatory data were dispersed across national systems with varying levels of maturity, transparency, and accessibility, leading to information asymmetries among countries and duplication of regulatory efforts.
In response, PAHO/WHO—following extensive consultations with National Regulatory Authorities (NRAs), regional regulatory networks, academic institutions, and international partners—conceptualized PRAIS as a shared regional infrastructure. The platform was designed to complement national regulatory systems by facilitating access to regulatory intelligence, supporting capacity-building, and promoting regulatory convergence, without interfering with national decision-making authority.
Over more than a decade of operation, PRAIS evolved into a modular digital ecosystem supporting transparency, collaboration, and regulatory capacity-building in the Americas.
PRAIS Legacy
Regional Regulatory Intelligence, Convergence, and Capacity-Building.
PRAIS served as a comprehensive regional hub for regulatory intelligence by consolidating a broad range of regulatory information, technical guidance, and observatory outputs covering access and rational use of health technologies; intellectual property, policy, governance, and management; research, development, and innovation (R&D&I) policies; and regulatory data related to medicines, medical devices, radiological health and radiological safety infrastructure, safe blood systems, and health technology assessment frameworks.
Through its thematic modules—including Regulatory Observatories (providing regional indicators of regulatory system functionality that supported the development of National Regulatory Authorities of Regional Reference – NRAr), MEDLIST (a comparative compilation of national essential medicines lists in the Region of the Americas), REDMA (the Program for the Exchange of Medical Device Adverse Event Reports among National Regulatory Authorities in the Region of the Americas), a document repository with more than 1,000 shared resources, and over 65 Communities of Practice—PRAIS reduced information fragmentation and significantly improved access to timely, structured regulatory knowledge across English-, Spanish-, and Portuguese‑speaking countries. Collectively, these tools facilitated peer‑to‑peer exchange, comparative analysis, and sustained capacity‑building among regulators and technical experts, contributing to regulatory convergence and strengthened regulatory systems in the Americas.
Digital Public Good for the Region
PRAIS functioned as a regionally owned digital public good, reinforcing principles of equity, transparency, and public health relevance, and supporting countries with differing levels of regulatory maturity.
Crisis and Collaboration Enabler
By providing secure collaboration environments and trusted information channels, PRAIS strengthened coordination and information‑sharing among regulatory authorities, particularly in situations requiring rapid and reliable exchange of regulatory information. This role proved especially relevant during public health emergencies, including the COVID‑19 pandemic, when PRAIS supported timely communication, regulatory convergence, and collaborative responses among regulatory actors in the Region of the Americas.
