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Announcement

Certara and ANVISA Partner to Launch eCTD 4.0 Submissions of Drug Applications in Brazil Through GlobalSubmit™ software

Certara’s GlobalSubmit software empowers ANVISA’s digital modernization by enabling fully electronic, structured eCTD 4.0 submissions to streamline reviews and accelerate patient access to new therapies.

Radnor, PA. – November 13, 2025 – Certara, a global leader in model-informed drug development, announced a partnership with Brazil’s National Health Surveillance Agency (ANVISA) to enable electronic Common Technical Document (eCTD) 4.0 submissions using the Certara GlobalSubmit software. The collaboration advances ANVISA’s digital modernization strategy and aligns Brazil with global regulatory standards.

Used by leading regulators and biopharmaceutical companies worldwide, GlobalSubmit integrates authoring, publishing, validation, and review in one product. Its robust validation and lifecycle management features ensure submissions meet ICH specifications while supporting scalability as Brazil’s review volume grows.

Through the partnership, ANVISA will deploy GlobalSubmit Review and Publish to securely receive and evaluate eCTD 4.0 dossiers. Certara’s regulatory operations team will provide technology-enabled services to support implementation, training, and ongoing optimization. ANVISA selected GlobalSubmit over other solutions for its streamlined submission workflows, reduced manual handling, improved data integrity, and faster regulatory decision-making.

The eCTD 4.0 standard—developed by the International Council for Harmonisation (ICH)—transforms regulatory submissions from static documents into dynamic, data-driven structures. Built on HL7’s Regulated Product Submission framework, it enhances metadata management, document lifecycle tracking, and content reuse. These capabilities improve transparency, automation, and efficiency in regulatory reviews.
ANVISA’s move to eCTD 4.0 marks a major milestone in Latin America’s regulatory evolution, positioning Brazil as a regional leader in digital regulatory transformation.

About Certara

Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com.

Certara contact:

Sheila Rocchio
[email protected]

Media contact:

Alyssa Horowitz
[email protected]

Webinar
GlobalSubmit eCTD 4.0 Webinars

The world of electronic regulatory submissions is about to change with the introduction of eCTD v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents.

Access all our eCTD 4.0 webinars

ANVISA Announcement FAQs

What does the Certara and ANVISA partnership mean for eCTD 4.0 submissions in Brazil?

Certara’s partnership with ANVISA introduces eCTD 4.0 submissions through GlobalSubmit™, marking Brazil’s transition to a fully digital regulatory system. This collaboration streamlines application reviews, reduces manual processes, and aligns Brazil with international ICH eCTD 4.0 standards.

What is eCTD 4.0 and how does it improve regulatory submissions?

The eCTD 4.0 standard, developed by the International Council for Harmonisation (ICH), replaces static document submissions with structured, data-driven formats. It improves metadata management, document tracking, and content reuse—making drug application reviews faster, more transparent, and more efficient.

How will Certara’s GlobalSubmit™ software help ANVISA modernize regulatory reviews?

GlobalSubmit™ integrates publishing, validation, and review into one secure platform. For ANVISA, it enables seamless eCTD 4.0 dossier management, improved data integrity, and faster regulatory decisions—accelerating patient access to new medicines in Brazil.

Learn more about GlobalSubmit™

Certara GlobalSubmit eCTD Software empowers regulatory professionals to publish, validate, and review submissions seamlessly, as a team.

View GlobalSubmit™Schedule a demo

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