PMDA is the first agency to make eCTD v4.0 mandatory, effective April 1, 2026. EMA follows in 2026 with mandatory use for centrally authorised products (CAPs). FDA accepts eCTD v4.0 on a voluntary basis for new applications since September 16, 2024, with a mandatory date expected around 2029. Health Canada, Swissmedic, and TGA each have their own pilot and transition schedules. If you file in more than one region, your publishing strategy must handle both v3.2.2 and v4.0 in parallel through the end of the decade.
What is eCTD v4.0?
eCTD v4.0 is the current ICH standard for electronic regulatory submissions of drug and biologic dossiers. It is specified by ICH M8 and builds on the HL7 Regulated Product Submission (RPS) message standard. The specification reached Step 4 in 2022.
Where v3.2.2 uses a folder-and-XML structure with separate Module 1 and Modules 2 through 5 files, v4.0 uses a single XML exchange message that encapsulates all modules in one package. Module 1 remains region-specific. Modules 2 through 5 are shared across ICH regions.
The v4.0 package has four components: XML Message, XML Schema, Controlled Vocabularies, and the regional Files and Folders structure. The full ICH implementation package is available on the ICH eCTD v4.0 page.
Backward compatibility is not technically possible. A dossier that starts in v3.2.2 must either stay in v3.2.2 for its lifecycle or be fully re-baselined in v4.0 at a planned switch point. Each agency is defining its own re-baselining policy.
Comparison: eCTD v4.0 status by jurisdiction
| Agency | Voluntary acceptance | Mandatory date | Primary source |
|---|---|---|---|
| PMDA (Japan) | Pilot Q2 2021, voluntary from 2022 | April 1, 2026 | PMDA eCTD guidance |
| EMA (EU) | Optional for CAPs since 2024 | 2026 for CAPs, NAPs follow | EMA eCTD v4.0 projects |
| FDA (US) | New applications since September 16, 2024 | Projected 2029 (not finalized) | FDA eCTD v4.0 page |
| Health Canada | Pilot 2023, optional from 2026 | Mandatory 2027 or 2028 (draft guidance) | Health Canada draft M1 guide |
| Swissmedic | Implementation Guide published March 2023, v3.2.2 still mandatory baseline | Not yet announced | Swissmedic eCTD page |
| TGA (Australia) | AU Module 1 v4.0 published; voluntary acceptance | Not yet announced | TGA eCTD v4.0 AU Module 1 |
Japan's April 1, 2026 deadline is the first genuinely hard cutoff globally. After that date, applications in non eCTD v4.0 format can be rejected or returned for re-submission.
What changes between v3.2.2 and v4.0
| Aspect | v3.2.2 | v4.0 |
|---|---|---|
| Structure | Folder tree with backbone XML per sequence | Single HL7 RPS XML exchange message |
| Module organisation | M1 regional XML, M2 through M5 ICH XML | Unified message across all modules, with regional M1 content |
| Lifecycle | Sequence-based, leaf replacement model | Keyword and grouping metadata, richer lifecycle operations |
| File handling | Directory structure mirrors dossier | Files referenced by metadata, not folder position |
| Controlled vocabularies | Limited | Extensive (document context, submission context, product context) |
| Backward compatibility | N/A | Not compatible with v3.2.2 in the same lifecycle |
| Two-way communication | No | Planned, not yet live at most agencies |
The practical consequence is that a publishing tool configured for v3.2.2 cannot simply emit v4.0 by toggling a setting. Vendors have released v4.0 capable versions (Veeva Vault Submissions, Lorenz docuBridge, Extedo eCTDmanager, among others), but reconfiguration requires re-mapping document types to v4.0 controlled vocabularies, testing against each agency's regional validator, and training authors on the new keyword and grouping fields.
FDA: voluntary since September 2024, mandatory not yet set
FDA began accepting new applications (NDAs, BLAs, ANDAs, INDs, DMFs) in eCTD v4.0 on September 16, 2024 (FDA eCTD Submission Standards). Only new applications currently: forward compatibility for existing v3.2.2 applications is not yet available, and FDA has not announced a mandatory date. FDA has stated it will provide advance notice before v4.0 becomes the only supported format.
FDA offers an optional sample submission process where sponsors can transmit a v4.0 test sample for agency feedback before a real filing (Submit an eCTD v4.0 or Standardized Data Sample). Sponsors planning their first v4.0 NDA or BLA should use this process.
EMA: mandatory for CAPs in 2026
EMA opened optional use of eCTD v4.0 for centrally authorised products in 2024. Mandatory use for CAPs begins in 2026, with a staged extension to nationally authorised products (NAPs) afterwards. The EU eCTD v4.0 Practical Guidance v1 on the EMA eSubmission portal is the operational reference, alongside the EMA M8 scientific guideline page.
Because v4.0 is not backward compatible with v3.2.2, EMA has confirmed that dossiers active in v3.2.2 will continue in v3.2.2 through their lifecycle. Sponsors may switch a dossier to v4.0 only at a defined baseline point, not mid-sequence.
PMDA: first to go mandatory, April 1, 2026
PMDA completed a technical pilot in Q2 2021 and opened voluntary use in 2022. From April 1, 2026, eCTD v4.0 becomes the only accepted electronic submission format for new drug applications in Japan. Japan-specific Module 1 requirements differ from FDA and EMA: metadata localisation, language handling, and structural requirements follow PMDA's regional implementation guide.
Teams filing their first PMDA submission after April 2026 must have a v4.0 capable publishing workflow with Japanese regional metadata, dual-language document handling, and PMDA's validator integrated into their QC step.
Try this in RegAid: What Module 1 differences exist between FDA, EMA, and PMDA eCTD v4.0?
Health Canada, Swissmedic, TGA
Health Canada released a draft guidance for the Canadian Module 1 Technical Implementation Guide for v4.0. Voluntary acceptance is expected from 2026. The mandatory date has been proposed as 2027 in one draft and 2028 in a later revision. Sponsors filing Canadian NDS or SNDS after 2027 should plan for v4.0.
Swissmedic published an eCTD v4.0 Implementation Guide in March 2023 but currently still mandates v3.2.2 with Swiss-specific Module 1 for pharmaceutical submissions (Swissmedic eCTD). No mandatory v4.0 date is announced.
TGA published the AU Module 1 and regional information for eCTD v4.0. Voluntary acceptance is open. No mandatory date announced.
How to plan your global submission strategy
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Map every active dossier to an agency and version. List each product, each jurisdiction, and the eCTD version currently in use for that dossier's lifecycle. This is the starting inventory.
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Identify your first mandatory cutoff. For most sponsors with a Japanese presence, that is April 1, 2026. For EU-only sponsors, it is the 2026 CAP mandate. Use the earlier of the two to anchor your program plan.
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Upgrade your publishing platform. Confirm your vendor supports v4.0 with regional M1 validators for each target jurisdiction. Budget time for controlled vocabulary mapping, author training, and parallel environment setup.
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Run sample submissions with each agency. FDA offers an explicit sample submission channel. PMDA's pilot acceptance continues. Use every opportunity to validate your output against the agency's live validator before a real filing.
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Define your re-baselining policy per dossier. Since v3.2.2 and v4.0 are not backward compatible in the same lifecycle, decide for each dossier whether to stay in v3.2.2 through the next few years or switch to v4.0 at a natural baseline point (a major variation, a renewal, a new indication).
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Align Modules 2 through 5 authoring across regions. The dossier content is shared across ICH regions, but controlled vocabularies and keyword metadata in v4.0 must be applied consistently. Inconsistencies across regional submissions trigger validator errors.
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Update your RIM (regulatory information management) system. v4.0 adds new metadata fields (document context, submission context, product context, keyword and grouping). Your RIM must capture those fields at authoring, not patch them in during publishing.
Common pitfalls
Treating v4.0 as a format toggle: v4.0 requires new content metadata at the source. A publishing tool cannot reliably invent document context and keyword metadata from a v3.2.2 dossier. Start at the authoring layer, not at publishing.
Missing the Module 1 regional differences: Module 1 is region-specific in both v3.2.2 and v4.0, but v4.0 Module 1 schemas differ per region. PMDA M1, FDA M1, EMA M1, and Health Canada M1 are four different XML schemas. A single generic v4.0 export will not validate in any region.
Assuming v3.2.2 dossiers can migrate mid-lifecycle: Re-baselining is a planned event, not a retrofit. Mid-lifecycle version switching is not supported by any ICH agency.
Skipping the agency validator: Each agency provides a regional validator (or accepts a sample submission). A dossier that passes a generic eCTD validator can still fail an agency-specific validator over regional M1 rules. Validate against the agency's own tool before filing.
Forgetting that FDA voluntary still means advance prep: FDA has no mandatory date, but once it announces one, the window will be short because v4.0 requires upstream changes. Sponsors who wait for the FDA mandate to start planning will miss it.
Key takeaways
- PMDA is the first agency to make eCTD v4.0 mandatory, effective April 1, 2026, per PMDA's electronic submission program
- EMA mandates v4.0 for centrally authorised products in 2026, with NAPs to follow (EMA eCTD v4.0 projects)
- FDA accepts v4.0 voluntarily for new applications since September 16, 2024; mandatory date not yet announced, projected around 2029 (FDA eCTD v4.0 page)
- Health Canada targets 2027 or 2028 for mandatory use; Swissmedic and TGA have no announced dates
- eCTD v4.0 is not backward compatible with v3.2.2; a dossier must be re-baselined at a planned switch point
- The transition is an authoring and RIM change, not a publishing toggle
How RegAid helps
RegAid covers the FDA eCTD v4.0 guidance package, EMA's M8 scientific guideline, PMDA regional implementation notices, Health Canada's draft Module 1 technical implementation guide, and the underlying ICH M8 specification. Ask "What are the Module 1 differences between FDA and PMDA eCTD v4.0?" or "What is the EMA mandatory date for eCTD v4.0 CAPs?" and get a cited answer with links to the agency source documents.