Frequently Asked Questions
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 |
- 2022 Onwards: Pilot testing by PMDA
- 2025–2026: Voluntary submissions encouraged
- April 2026: Mandatory adoption
Stay informed through official PMDA updates.
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.
- New Drug Applications (NDAs, BLAs, ANDA)
- New Master Files (DMFs)
- Subsequent submissions
- Post-marketing changes
- Renewals and re-examinations
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- Reduced submission redundancy
- Enhanced regulatory lifecycle control
- Streamlined global submissions
- Improved data quality and compliance
- Long-term cost savings
- Technology upgrades and validation
- Staff training and SOP updates
- Metadata mapping complexities
- Managing parallel submissions during transition
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