Overview on eCTD v4.0 submission to PMDA Japan
Last updated on: July, 2025
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is poised to move from eCTD v3.2.2 to v4.0 and is already working toward global alignment. An implementation timeline set from 2022 marks the commencement of a pilot phase, progressing towards mandatory compliance by 2026, creating an urgent need for preparedness among pharma companies to avert rejection during submission evaluations.
Freyr Solutions offers support for migration to eCTD v4.0 aligned with PMDA requirements ensuring compliance with complex local standards. Our comprehensive competency guarantees careful compilation, review, QC, validation, and submission of electronically formatted Common Technical Documents (eCTDs) for pharmaceuticals, biologics, and innovator companies in Japan.
Why prefer Freyr as a Partner for Japan eCTD v4.0 Submissions?
- PMDA-Compliant Submissions - Expertise in Japan-specific eCTD v4.0 requirements
- End-to-End Solution - From dossier preparation to final submissions, all in one place
- AI-based Regulatory Technology - PMDA Compliant, freya.submit for Japan eCTD v4.0 Submissions
- AI-driven advanced tools for effective eCTD publishing
- Local Expertise - Deep understanding of Japan's regulatory environment
- Fast Turnaround - Accelerated submissions timetables with the on-ground Japan experts
Key Features of Japan eCTD v4.0
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Mandatory, starting 2026
For new drug applications (NDAs) in Japan
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Strict PMDA validation rules
Non-compliance will lead to rejection
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Lifecycle management
For updates and sequences
Technology Changes
File Format Revolution
| Component | eCTD v3.2.2 | eCTD v4.0 | Technical Impact |
| Primary Format | PDF-centric | XML-native | Requires XML authoring tools |
| Metadata | Limited PDF properties | Extensive XML metadata (ISO 21972) | New tagging workflows |
| Controlled Vocabularies | NA | Regional and ICH Specific Vocabularies | Harmonized Data |
| Attachments | PDF/Word | PDF optional (XML primary) | Legacy content conversion |
Japan Note: PMDA requires Japan-specific XML namespace extensions for local product codes.
Lifecyle management new workflow
Freyr's Japan eCTD v4.0 Submission Services
eCTD Dossier Preparation & Publishing
- Paper file conversion into Japan eCTD v4.0 format – as per both regional and ICH guidelines
- Document Level Publishing - Bookmarking, hyperlinking, and PDF optimization
- Submission Level Publishing - XML backbone generation, external linking, keywords & lifecycle management
Regulatory Submission & Validation
- PMDA-specific validation checks
- Technical compliance check prior to submission
- eCTD submission via PMDA's Electronic Submission Gateway
Post-Submission Support
- Management of PMDA query and deficiency management
- Lifecycle management (amendment, variation, renewal)
- Change control and versioning updates
Consulting & Training
- Gap analysis for Japan eCTD v4.0 readiness
- Training in-house teams on Japan eCTD v4.0 requirements
- Regulatory strategy for streamlining approvals
Freyr's eCTD v4.0 Key Differentiators
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Japan-Specific Expertise
Dedicated Japan team with PMDA requirements experience
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AI-Powered Validation
Reduce errors prior to submission
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Cost-Effective Solutions
Minimize rework and delay
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Seamless Integration
Works with existing regulatory processes
Frequently Asked Questions
What is eCTD v4.0?
eCTD v4.0 (Electronic Common Technical Document version 4.0) is the latest international standard for electronic Regulatory submissions developed by International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. eCTD v4.0 enables improved workflows, enhanced lifecycle management, flexible metadata, and two-way communication between sponsors and Regulatory authorities.
Is eCTD v4.0 mandatory in Japan?
Presently, eCTD v4.0 is not mandatory in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) is conducting pilot submissions and finalising guidance, with full adoption mandated from April, 2026. Early preparation is recommended to ensure compliance.
What are the key differences between eCTD v3.2.2 and v4.0?
| Features | eCTD v3.2.2 | eCTD v4.0 |
| Metadata | Fixed and limited | Flexible and reusable |
| Communication | One-way submissions | Supports two-way communication |
| File Structure | Submission-based | Content-centric, reusable files |
| Lifecycle Management | Redundant documents | Streamlined with document reuse |
| Technical Standard | ICH-based | HL7 RPS-based |
What is Japan’s PMDA timeline for eCTD v4.0 implementation?
- 2022 Onwards: Pilot testing by PMDA
- 2025–2026: Voluntary submissions encouraged
- April 2026: Mandatory adoption
Stay informed through official PMDA updates.
Why is Japan adopting eCTD v4.0?
eCTD v4.0 offers advantages such as improved efficiency, increased usability, enhanced compliance, forward compatibility and controlled vocabularies and it is important to note that Japan is taking a lead and is one of the first regions to mandate eCTD v4.0. Japan aims to harmonize with global regulatory standards (ICH M8), improve submission efficiency, reduce redundancy, and enhance interoperability with agencies such as USFDA and EMA.
Which are the Health Authorities across the globe who already accept eCTD v4.0 submissions?
US FDA:
The FDA has been actively involved in the transition to eCTD v4.0, with a pilot and voluntary submissions since 2024, followed by mandatory implementation in 2029.
European Medicines Agency (EMA): The EMA is transitioning to eCTD v4.0 for both centrally authorized products (CAPs) and nationally authorized products (NAPs). Pilot submissions for CAP is encourages from 2025 onwards.
Health Canada:
Health Canada also participated in a technical pilot in 2023, with voluntary implementation expected to start in 2026 and mandatory implementation in 2028.
Japan's PMDA:
Japan's MHLW/PMDA completed a technical pilot in Q2 2021, with voluntary implementation in 2022 and a mandatory implementation in 2026.
The transition to eCTD v4.0 is a global effort to streamline regulatory submissions and improve communication between regulatory agencies and pharmaceutical companies. The International Council for Harmonisation (ICH) is a key organization driving this harmonization.
Which PMDA drug submission categories are impacted by eCTD v4.0?
- New Drug Applications (NDAs, BLAs, ANDA)
- New Master Files (DMFs)
- Subsequent submissions
- Post-marketing changes
- Renewals and re-examinations
Are new tools required for eCTD v4.0 compliance?
Yes. Companies will need HL7 Regulated Product Submission (RPS)-compliant publishing software, metadata management tools, lifecycle tracking solutions, and updated document management systems.
Check out freya.submit a PMDA compliant, eCTDv4.0 ready tool.
Check out freya.submit a PMDA compliant, eCTDv4.0 ready tool.
Is eCTD v4.0 backward compatible with v3.2.2?
No. eCTD v4.0 uses a different technical framework and is not backward compatible. A migration strategy will be necessary for managing both formats during transition.
Can companies reuse global eCTD v4.0 submissions in Japan?
Partial reuse is possible, but localization is required to meet Japan-specific metadata, language, and structural requirements.
What benefits does eCTD v4.0 bring to Japanese pharma companies?
- Reduced submission redundancy
- Enhanced regulatory lifecycle control
- Streamlined global submissions
- Improved data quality and compliance
- Long-term cost savings
What challenges should organizations expect with respect to eCTD v4.0?
- Technology upgrades and validation
- Staff training and SOP updates
- Metadata mapping complexities
- Managing parallel submissions during transition
How can Freyr assist with Japan’s eCTD v4.0 transition?
Freyr offers end-to-end support for eCTD v4.0 Adoption, Submission Services, Technoology and Process consulting – for both global and regional teams. Apart from these, Freyr is ready to help you on readiness assessments, metadata modeling, content migration, PMDA-compliant packaging, and bilingual trainings for Regulatory teams.
Ready to master eCTD v4.0 in Japan?
Join Freyr’s in-person eCTD v4.0 Workshop on August 28, 2025 in Tokyo! Learn from experts, explore real-world demos, and prepare your organization for the future of Regulatory submissions.