eCTD Adoption in LATAM – Current Landscape

Freyr 3D Series eCTD Adoption in LATAM Part 1 – Current Landscape

3 min read

eCTD in Latin America: Progress, Gaps, and the Road to Standardization

The digital transformation of regulatory processes is no longer optional—it is essential. In Latin America, this shift is unfolding at uneven speeds but with a shared goal: to strengthen technical and regulatory frameworks and progressively align with international standards such as the electronic Common Technical Document (eCTD).

As of today, no country in the region has fully implemented eCTD v4.0 according to the ICH Implementation Guide. However, the momentum is evident. Regulatory authorities are showing increasing interest in modernizing systems, improving document traceability, and transitioning from fragmented structures to more integrated formats like the CTD.

This first article in the Freyr 3D Series provides a regional snapshot of that evolution, with a focus on institutional and regulatory developments that could pave the way for broader eCTD adoption in the near future.

eCTD: More than a format—it’s a platform for regulatory convergence

The eCTD is not just an electronic file. It’s a standardized system that enables regulatory agencies to receive, review, and archive submissions in a structured, efficient, and traceable manner. Organized into interdependent technical modules, it supports full dossier lifecycle management and promotes international harmonization.

Already adopted by agencies such as the FDA, EMA, Health Canada, and Japan’s PMDA, the eCTD is a key step toward greater interoperability, reduced review times, and enhanced consistency in technical documentation.

For Latin America, implementing eCTD represents not only an operational upgrade but a strategic move toward a more aligned, modern, and trustworthy regulatory environment.

Where do we stand? A technical overview of the region

Only a few countries in the region have begun exploring eCTD v4.0 adoption. Their progress is reflected in the enhancement of digital platforms, partial adoption of CTD structures for certain procedures, and increasing interest in aligning with international standards.

This overview does not aim to compare countries directly, but to provide a cross-sectional analysis of advances that, while heterogeneous, point to a common trend: digital regulatory transformation.

The following insights are based on official sources (ANVISA, COFEPRIS, INVIMA, ANMAT), ICH guidelines, and EFPIA’s 2023 technical white paper.

Brazil – ANVISA

Brazil has been a regional pioneer in digital regulatory innovation. The 2024–2025 Regulatory Agenda prioritizes tools such as electronic leaflets, document interoperability, and modernization of platforms like Datavisa. While it does not formally require eCTD v4.0 or v3.2.2, CTD structures are already in use, especially for complex products. Brazil appears to be laying the groundwork for future eCTD adoption, with projected timelines aligning with those outlined in ICH documentation.

Mexico – COFEPRIS

The launch of DIGIPRiS marked a milestone in digital regulatory procedures. This platform allows COFEPRIS to manage applications more efficiently and transparently. However, it does not yet operate under a formal eCTD structure. Efforts are still focused on optimizing internal workflows and enhancing technical quality. Mexico’s intention to become a WHO-Listed Authority (WLA) further highlights the need to adopt international standards in the mid-term.

Colombia – INVIMA

INVIMA has consolidated a single-window system for digital dossier submissions. While this represents significant progress, it does not yet require CTD or eCTD structures, nor is there a public plan for formal adoption. Nonetheless, the agency has expressed interest in improving pharmacovigilance and traceability systems, which could facilitate future technical harmonization.

Argentina – ANMAT

ANMAT has focused on digitalizing key processes, especially in pharmacovigilance and document control. Although it has strengthened platform interoperability, eCTD is not yet mandatory for new submissions. However, the agency’s technical capacity and gradual implementation strategy may support integration into global standards in the medium term.

Emerging regional patterns

Despite varying levels of progress, specific common patterns can be identified:

A shared effort to digitalize regulatory workflows
Strengthening of institutional platforms and technical capabilities
A clear—though sometimes undeclared—intention to align with international standards

As the EFPIA white paper notes, effective eCTD implementation in middle-income countries will depend less on immediate regulatory changes and more on progressive development of infrastructure, processes, and internal competencies.

What should the industry be asking?

In this transitional phase, companies in the pharmaceutical and life sciences sectors should be asking themselves:

Are our dossiers already structured in CTD format, or are we using traditional formats?
How well aligned are our technical teams with projected regulatory changes?
Do we have local partners who understand institutional dynamics and can anticipate future shifts?

These are not theoretical questions—they are essential for planning resources, mitigating risks, and gaining agility in the face of upcoming regulatory transformations.

Fostering a culture of regulatory readiness

In a region without a uniform regulatory timeline, anticipation becomes a competitive advantage. It’s not about predicting exactly when eCTD will be mandatory in each country, but understanding that its adoption is part of an inevitable shift toward standardization, efficiency, and convergence.

At Freyr, we don’t just track this evolution—we translate it into concrete actions, specialized guidance, and tailored solutions. Our support combines technical expertise, strategic insight, and deep understanding of global, regional, and local regulatory environments. We help our partners not only comply with evolving requirements but also make proactive, sustainable decisions aligned with both regulatory and business objectives.