,2 min read
The discussion around the Electronic Common Technical Document (eCTD) has been gaining relevance across Latin America, as explored in our Freyr 3D Series, which analyzed its regional evolution and the challenges of adoption in various markets (read article).
Aligned with this regional momentum, Brazil’s National Health Surveillance Agency (ANVISA) has announced the signing of a contract to implement the eCTD, marking a crucial step toward the digital transformation of its regulatory processes.
The eCTD, already adopted by agencies such as the FDA and EMA, will serve as the foundation for Brazil’s future model of electronic submission and lifecycle management.
This initiative represents a decisive milestone for ANVISA, reflecting a commitment to improving efficiency, interoperability, and transparency within its regulatory ecosystem.
Although this announcement does not yet constitute a formal regulation, it signals the direction Brazil is taking toward full digitalization of regulatory submissions, positioning the country as a regional pioneer in adopting structured electronic formats.
The eCTD: A New Common Language for the Industry
More than a shift in format, the eCTD redefines how regulatory information is structured, presented, and maintained.
By adopting a modular, traceable digital structure, authorities can streamline dossier review, reduce manual workload, and enhance data traceability throughout the product lifecycle.
For Brazil, this transition aligns the national system with global ICH standards, enabling smoother interoperability with other regulatory agencies and reducing administrative burden for pharmaceutical companies.
It also lays the groundwork for a more agile, predictable, and transparent regulatory environment.
Preparing for the Transition
The implementation of the eCTD will require technical and organizational adjustments for companies operating in Brazil.
Pharmaceutical firms will need to strengthen document management systems, ensure traceability across CTD modules, and train regulatory teams in digital submission procedures.
Organizations that begin this transition early will be better prepared for the pilot phase, minimizing operational risks and ensuring consistency across their regulatory documentation.
Anticipating the change will not only facilitate compliance but also enable faster and more coordinated interactions with the authority.
Redefining the Path Toward Digital Regulation
This initiative by ANVISA goes beyond modernizing technology — it redefines how compliance, innovation, and competitiveness converge within the regulatory landscape.
Companies that embrace digital tools, data analytics, and automated compilation processes will gain efficiency, enhance quality control, and strengthen regulatory governance.
Collaborating with teams that combine global experience with local regulatory expertise will help organizations connect technical accuracy with strategic foresight.
In this process, the ability to integrate end-to-end digital frameworks and AI-driven solutions becomes essential to ensure interoperability, consistency, and long-term readiness.
Ultimately, ANVISA’s decision to adopt the eCTD marks a new stage of institutional maturity and alignment with international best practices.
Its implementation will require coordination, investment in digital infrastructure, and genuine commitment from companies to adapt their operations to the new electronic environment.
This evolution places Brazil at the forefront of regulatory modernization in Latin America, setting the stage for a more efficient, predictable, and globally connected regulatory future.
Contact usand discover how Freyr’s global regulatory ecosystem supports the pharmaceutical industry in navigating digital transformation with precision, agility, and foresight.