Around the Globe: Brazil
n October 2025, the Brazilian health regulatory agency ANVISA announced it signed a contract with the vendor to enable transitioning to the electronic common technical document (eCTD) format for regulatory submissions in Brazil, another step in the agency’s path to harmonize its documentation and processes with other global regulators for the review and approval of new medicines. “Implementation of eCTD represents a strategic step in ANVISA’s digital and regulatory transformation agenda,” explains Raphael Sanches Pereira, Head of Office for Medicines (small molecules) registration at ANVISA. “Beyond replacing paper-based or PDF-centric processes, eCTD establishes a structured, interoperable, and lifecycle-based framework for regulatory submissions, enabling greater efficiency, consistency, traceability, and data quality throughout the product lifecycle.” He explains the next steps in this new chapter for ANVISA in the following Q&A with Marcio Silva (Bayer Pharmaceuticals).
Importantly, eCTD implementation positions Brazil within the broader context of international regulatory convergence. As an active participant in ICH activities, ANVISA recognizes that the future of regulatory information management extends beyond document-based submissions toward structured data exchange and greater digitalization.
In this regard, the implementation roadmap is closely aligned with the evolution of the ICH M4Q (R2) guideline and the ICH M16 guideline. M4Q (R2) modernizes the Quality section of the Common Technical Document by introducing a more structured and data-driven approach to pharmaceutical quality information, creating opportunities for improved lifecycle management and greater regulatory efficiency. Likewise, M16 establishes the global standard for the electronic submission of regulatory information through eCTD, providing the framework necessary to support harmonized electronic submissions and future digital regulatory processes.
By adopting eCTD in alignment with these international standards, ANVISA is not only implementing a new submission format but also establishing the foundation for future regulatory innovation, enhanced data interoperability, and closer integration with the global regulatory ecosystem. Ultimately, this initiative strengthens the agency’s institutional capabilities while creating a more efficient and predictable environment for applicants and patients alike.
What are the formal phases of the eCTD implementation that will require participation from the regulated industry, and what are the key milestones associated with each phase?
System Development and Internal Validation
Technical configuration, Module 1 development, and internal testing by ANVISA.
External Adoption / Adaption Phase
After internal testing, it is expected that a guideline or similar document will be published with technical details and requirements for eCTD program. This phase is important for companies to have enough time to procure their own service providers and raise the costs.
Pilot Program
Limited regulatory submissions involving predefined application types and volunteer participants.
Assessment of technical performance, business processes, and user experience.
Transition Phase
Coexistence of current submission formats and eCTD for an established period.
Gradual expansion of submission categories accepted in eCTD is expected, but this has not yet been discussed.
Full Operational Implementation
Broader adoption across regulatory procedures, potentially culminating in mandatory eCTD submissions for specific application types.
Another point yet to be discussed is if there will be any opportunity for migration of legacy products.
Specific timelines and milestones will be communicated through official regulatory channels once implementation planning is finalized.
What could you share about testing and pilot phases, including eligibility criteria for company participation and the regulatory scope of submissions accepted during these stages? Additionally, will these phases focus on specific therapeutic areas, trial designs, or other defined submission types?
It is important to note that even before a pilot phase, gathering and organizing public information about system requirements and expectations is important for companies to procure their service providers properly, to make a pilot phase more fruitful and leverage the adoption of the tool in it.
At this stage, no decision has been made to restrict participation based on therapeutic area. The primary focus will be validating technical and procedural performance rather than evaluating specific scientific disciplines.
What regulatory transition model does ANVISA foresee for the eCTD, including potential coexistence periods between formats, acceptance of dossiers prepared in earlier eCTD versions, and the availability of an official validator for industry use?
Key principles under consideration include:
- Providing sufficient lead time before any mandatory implementation requirements;
- Establishing clear guidance on migration strategies for ongoing applications;
- Defining the treatment of dossiers prepared using earlier eCTD versions;
- Aligning technical specifications with internationally recognized standards whenever feasible.
Regarding validation, ANVISA recognizes the importance of consistent quality standards. Therefore, the availability of an official validation framework—or compatibility with recognized industry validators—will be evaluated to ensure predictable and harmonized implementation.
Implementing a regulatory system of this scale requires coordination across multiple areas of the agency. What have been the main internal coordination and governance challenges faced by ANVISA throughout this process?
- Harmonizing business requirements across different regulatory areas;
- Aligning technological development with evolving international standards;
- Managing organizational change and workforce readiness;
- Ensuring integration with existing regulatory systems and databases;
- Coordinating priorities among multiple stakeholders while maintaining ongoing operational activities.
To address these challenges, strong governance structures, clear decision-making processes, and continuous stakeholder engagement have been essential components of the implementation strategy.
ANVISA’s dedication to reduce the backlog of registration applications to be assessed, as well as efforts to become a WHO Listed Authority (WLA) according to WHO-GBT (Global Benchmarking Tool) requirements, are important challenges at this specific moment.
Based on international experience, what specific challenges related to Module 1 have other authorities faced during eCTD 4.0 implementation, and what strategies does ANVISA intend to adopt to mitigate these risks in the Brazilian context?
Common challenges include:
- Developing comprehensive regional metadata structures;
- Achieving consistency between business requirements and technical specifications;
- Managing changes to administrative forms and supporting documentation;
- Ensuring compatibility between industry systems and regulatory platforms;
- Providing clear guidance on lifecycle and document management practices.
To mitigate these risks, ANVISA intends to leverage international best practices, engage with global regulatory networks, and maintain close dialogue with industry stakeholders throughout the implementation process. Early testing, stakeholder consultation, and detailed technical guidance will be critical elements of the overall strategy.
What mechanisms for training, ongoing support, and regulatory governance are planned to sustain eCTD adoption?
The planned approach may include:
- Publication of implementation guides, technical specifications, and Frequently Asked Questions (FAQs);
- Webinars, workshops, and educational sessions for industry stakeholders;
- Dedicated communication channels for technical and regulatory questions;
- Ongoing stakeholder engagement forums to discuss implementation challenges and lessons learned;
- Governance mechanisms to monitor system performance, evaluate feedback, and support continuous improvement.
ANVISA recognizes the importance of ensuring that companies of different sizes and levels of eCTD experience can successfully transition to the new environment. For this reason, capacity-building initiatives and transparent communication will be fundamental components of the implementation strategy.