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

Radnor, PA. – 2025年11月13日 – 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.