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2 min read
What does it mean for the industry?
Latin America is at a turning point in its regulatory modernization journey. The progressive adoption of the electronic Common Technical Document (eCTD)—although still uneven across countries—is driving a transformation that goes beyond technical aspects and is beginning to reshape how regulatory agencies and the pharmaceutical industry interact.
While Part 1 of the Freyr 3D Series explored the current status of countries beginning their eCTD journey, this second installment focuses on the operational impact and strategic challenges this transition poses for marketing authorization holders.
1. Beyond the technical: a new way to engage with health authorities
The eCTD is not just a tool for organizing files. Its implementation fosters new forms of regulatory collaboration, encourages transparency, and redefines how companies interact with authorities. Regulatory agencies gain agility in reviewing submissions, managing product lifecycles, and ensuring traceability. At the same time, the industry must adapt to this new ecosystem, where formatting errors, incorrect naming, or upload issues can lead to automatic delays or rejections.
2. Internal preparation: capabilities, processes, and organizational culture
Adopting the eCTD involves more than just technology. Many companies must revisit their internal processes, assign clear ownership for dossier preparation and validation, integrate regulatory teams with specialized technical knowledge, and, in some cases, engage external eCTD publishing support.
This transition also demands a mindset of continuous improvement and organizational maturity in areas like document version control, information governance, and collaborative workflows.
3. Risks and costs of inaction
Lack of preparedness can result in hidden costs, from rework and delayed approvals to missed market opportunities. In countries like Brazil or Mexico, lacking the appropriate structure may exclude a company from the market or damage its standing with the authorities. Even in jurisdictions where eCTD is not yet mandatory, the regional trend points toward future convergence.
4. A shift in regulatory submission logic
The eCTD introduces a sequential, modular, and lifecycle-driven structure that requires companies to rethink how regulatory dossiers are built and maintained. Order, traceability, metadata, and update logic are key elements. This means moving away from outdated practices—such as scanned documents without bookmarks—and adapting versioning strategies to meet country-specific requirements.
5. Where are the strategic opportunities?
While compliance is the obvious driver, eCTD adoption opens new opportunities for companies seeking to differentiate:
- Position their operations as regulatory-ready for regional partnerships
- Reduce time-to-market through streamlined, well-structured dossiers
- Implement reliance models or parallel submissions when allowed
- Build stronger, more professional relationships with regulatory authorities
These advantages are only accessible to those who adopt an integrated view of regulatory strategy—aligning technical, legal, and commercial teams under a unified roadmap.
6. Building regulatory readiness with expert support
At Freyr, we not only monitor eCTD developments in each country—we help companies navigate this shift with strategic and technical support. Our regional expertise enables us to:
- Conduct eCTD maturity and readiness assessments
- Design scalable transition strategies
- Support dossier preparation from planning to submission
- Strengthen internal capabilities through training and consultative guidance
The transition to eCTD is a marathon, not a sprint. And while countries across LATAM are at different stages, the benefits of early action—in preparation, strategy, and foresight—will become increasingly evident.
Is your team exploring regulatory digitalization?
Let’s talk about how to take the first step. Contact us.
