Why eCTD v4.0 is Critical for Japan’s Regulatory Future

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is set to make eCTD v4.0 submissions mandatory by 2026. This move follows a successful pilot in the second quarter of 2021 and voluntary adoption beginning in 2022. As global regulatory frameworks converge and dossier volumes continue to rise, regulatory teams face growing complexity—tighter deadlines, greater scrutiny, and the need for precision across multiple regions.

In this environment, life sciences teams require a robust, unified Regulatory Information Management System (RIMS) to manage workflows, ensure compliance, and meet submission deadlines efficiently. A future-ready system like freya fusion integrates intelligence, automation, and collaboration to support regulatory teams every step of the way.

In this blog, we’ll cover:

• Best practices for eCTD v4.0 submissions based on Freyr’s experience with PMDA, FDA, and EMA

• How to choose the right publishing software for eCTD v4.0

• A phased implementation checklist for successful submissions in Japan
  Learn more in our step-by-step guide for Japan eCTD v4.0 submissions.

Best Practices for Japan eCTD v4.0 Submissions

Drawing from hands-on experience with global clients and health authorities, we recommend the following best practices for seamless eCTD v4.0 submissions to the PMDA:

 Understand ICH and PMDA 4.0 Requirements

• Study eCTD v4.0 guidelines, ICH standards, PMDA-specific rules, controlled vocabularies, and validation criteria

• Attend expert-led workshops to stay updated on regulatory changes

 Review Existing Submission Processes

• Conduct a gap analysis comparing current workflows against new eCTD v4.0 requirements

• Identify compliance gaps, outdated tools, and manual processes that need upgrading

 Upgrade Tools, Software, and Processes

• Implement compliant publishing software that supports eCTD v4.0 structure, validations, and submission rules

• Ensure integration with existing systems for seamless metadata and document management

 Collaborate with Regulatory Experts

• Partner with end-to-end regulatory service providers for process optimization, compliance, and technology upgrades

• Work with industry leaders to refine workflows and stay aligned with the latest regulatory trends

 Invest in Training

• Provide process-specific training on eCTD v4.0 requirements, workflows, and software usage

• Offer hands-on sessions, pilot submissions, and case studies to build team confidence

 Conduct Pilot Submissions

• Run test submissions before full-scale implementation to identify gaps and ensure readiness

• Validate end-to-end workflows, from document creation to final submission acknowledgment

Selecting the right technology partner is key. freya fusion is Freyr’s AI-powered platform that supports efficient, compliant, and transparent submissions—ensuring regulatory success in Japan and beyond.

Key Components of eCTD v4.0 Implementation

 Single Submission-Unit Architecture

The hallmark of eCTD v4.0 is the single XML package that combines Modules 1–5. No more managing separate M1 and M2–M5 files—just one structured, error-resistant submission.

 Document Lifecycle Management

• UUID Reuse: Track documents granularly and reuse content across submissions without duplication

• Context-of-Use Keywords: PMDA and ICH-driven metadata ensure correct sectioning and navigation

• Lifecycle Operations: Support one-to-one, one-to-many, and many-to-one document relationships seamlessly

• Controlled Vocabularies (CVs): Standardized metadata representation ensures consistency and auditability across submissions

These features make eCTD v4.0 submissions more reliable, efficient, and future-proof.

Step-by-Step Checklist for eCTD v4.0 Success in Japan

Phase 1 – Gap Assessment & Planning (3–6 Months Before Submission)

• Attend workshops and webinars to understand UUIDs, lifecycle changes, sequence rules, and controlled vocabularies

• Perform a thorough review of your existing submission process

• Assess whether current tools support HL7 schemas, PMDA CVs, and global standards

• Use regulatory intelligence tools to monitor guidance changes and align internal SOPs accordingly

• Train teams on software features and update standard operating procedures

Phase 2 – Partner Selection, System Implementation & Testing (2–3 Months Before Submission)

• Identify and engage regulatory partners offering both global expertise and local operations

• Integrate publishing software with your document management system

• Run validation tests using sample exchanges and sequence-level publishing scenarios

• Conduct pilot submissions with real-world data to fine-tune workflows

• Review outputs using eCTD v4.0-compliant validators

Phase 3 – Content Preparation (1–2 Months Before Submission)

• Collect and tag regional administrative forms with UUIDs and metadata

• Break down CTD summaries into XML-ready sections for reuse

• Assign controlled vocabulary values for Quality, Non-Clinical, and Clinical data

• Validate metadata and conduct pre-submission checks

Phase 4 – Final Submission (Weeks Before Submission)

• Run final validation to ensure all UUIDs are linked and metadata is correct

• Upload the completed package to the PMDA’s eCTD Gateway

• Track submission acknowledgments and status in real-time dashboards

With tools like freya fusion—an industry-first AI-powered RIMS—you can implement these steps with confidence and efficiency.

Why eCTD v4.0 is a Game Changer—and How to Stay Ahead

eCTD v4.0 isn’t just an upgrade—it’s a transformation in how regulatory submissions are prepared, validated, and reviewed. By adopting best practices and leveraging advanced tools, you can:

✔ Reduce manual work through AI-driven validation
✔ Improve compliance with real-time controlled vocabulary updates
✔ Future-proof your submission workflows with UUID reuse and lifecycle management
✔ Accelerate approvals with streamlined document management

Learn more about how freya fusion is helping organizations stay ahead in regulatory operations across Japan and globally.

Final Thoughts

The shift to eCTD v4.0 represents a new era in regulatory compliance—one that demands precision, collaboration, and smarter technology. With the right approach and tools, your organization can not only meet PMDA requirements but also build a competitive advantage.

Discover how Freyr’s solutions can help you master eCTD v4.0 and streamline your regulatory processes. Explore the possibilities today at Freyr Japan and start transforming how you approach compliance.

📘 Read the complete guide: Japan eCTD v4.0 Submission Checklist – A Step-by-Step Guide.

🚀 Ready to get started? Learn how freya fusion is helping teams succeed in Japan’s regulatory landscape.