Regulatory Submission Checklists for 2026: FDA, EMA, MHRA, TGA, Health Canada

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Keeping submission decks clean, technically valid and regulator-ready in 2026 means more than perfect science — it means following evolving electronic standards, updated Module-1 requirements, and country-specific administrative changes. Below is a practical, ready-to-use checklist for each major regulator (FDA, EMA, MHRA, TGA, Health Canada) plus quick tips to avoid the most common roadblocks when you hit “submit.”

Quick overview — what’s changed for 2026

Regulators continue to push electronic standards and stricter validation checks; eCTD compliance and Module 1 administrative details are now central to technical validation.
National agencies (MHRA, TGA, Health Canada) are updating variation and procedural rules that will affect format, timing and the way post-authorisation changes are classified.

1) FDA — filing checklist (CDER/CBER)

Key requirements

Submit in eCTD format per current FDA eCTD standards; use the latest validation criteria and the FDA’s eSubmission guidance. Ensure file naming, sequence structure (backward-compatible), and representative M1 administrative data are correct.
FDA pre-submit checklist (practical):
- Confirm eCTD version & validation tool alignment (use FDA-published validation criteria).
- Module 1: cover letter, applicant contact details, application form(s), and regional-specific administrative documents — confirmed and machine-read.
- File integrity: run the FDA validation tool locally, resolve all fatal/major errors.
- Security & transfer: confirm ESG/NextGen certificate and transfer method accepted by FDA at time of submission.
- Human factors: final proofreading of Module 1, signatures, and redaction of confidential information.

2) EMA — filing checklist (Centralized / NCAs)

Key requirements

EMA’s eSubmission portal enforces technical validation tied to EU M1 specifications — ensure your sequence complies with the current M1 version and validation criteria in use (check recent updates before submission).
EMA pre-submit checklist:
- Validate eCTD sequence against the EU M1 spec and the latest validation criteria.
- Module 1 tailored for EMA: national contact points, EU-specific forms, and any paper annexes must be mirrored by Module 1 metadata.
- Submission timing: confirm procedure calendars and deadlines (particularly for centralized procedures and variations).
- Post-submission: Prepare for rapid Q&A cycles; assemble a cross-functional rapid-response team (regulatory, CMC, clinical).

3) MHRA (UK) — filing checklist

Key Requirements

The MHRA has revised variation and procedural guidance affecting documentation requirements and timelines for 2026 (including new variation categories effective in 2026). Check the MHRA guidance pages for variations and recognition procedures ahead of submission.
MHRA pre-submit checklist:
- Confirm which route applies (national MAA, recognition procedures, or new international recognition processes) and follow the six-week eligibility/notification windows where required.
- Administrative evidence: local Qualified Person, UK contact, and batch release plans clearly stated.
- For clinical trial submissions: note impending regulatory changes in 2026 that may affect timelines and documentation.

4) TGA (Australia) — filing checklist

Key requirements

TGA expects eCTD format for prescription medicine applications; Module 1 contains Australia-specific admin info (check TGA Module-1 specs). Confirm the TGA’s accepted eCTD versions and the Module-1 layout.
TGA pre-submit checklist:
- Use TGA Module-1 specifications: local applicant details, product information, and local regulatory declarations.
- Confirm whether submission must be eCTD or can be non-eCTD for specific activities — the TGA page lists allowed formats by activity.
- Validate technical package with the TGA validation tools; check for required cover letters and fee payment evidence.

5) Health Canada — filing checklist

Key requirements

Health Canada accepts eCTD and non-eCTD electronic formats depending on activity; follow Health Canada guidance documents for filing and format selection.
Health Canada pre-submit checklist:
- Confirm submission format required for your regulatory activity (eCTD vs non-eCTD).
- Ensure administrative dossier (forms, GMP declarations, contact details) is consistent with Module 1 expectations for Canada.
- Run Health Canada’s technical checks and ensure encrypted transfer method and applicant credentials are in place.

Cross-agency operational checklist (apply to every submission)

Validate locally with each agency’s validation tools; resolve fatal errors before upload.
Module 1 accuracy: administrative metadata mismatches are the top technical rejection cause — double-check names, addresses, and eCTD sequence titles.
File compression & bookmarks: ensure PDFs are text-searchable and bookmarks match table of contents.
Signatures & certs: QP/QPPV statements, GMP certificates and authorizations must be current and attached.
Transfer readiness: confirm certificates/SSL and the accepted transfer method (ESP/ESG/agency portal) ahead of submission.
Stakeholder alignment: legal, labeling, CMC, clinical and publishing teams do a final read for redactions and consistent numbering.

Common pitfalls and how to avoid them

Outdated module-1 metadata — keep a single source of truth for administrative data and regenerate M1 on every sequence.
Validation surprises — run the agency’s validation tool as the final step; treat any fatal error as a blocker.
Late certificate expiries — SSL and digital signature certs can block uploads; track expiry dates for all transfer certificates.
Variation misclassification — read agency-specific variation Q&As before filing to avoid wrong procedure choice (MHRA/EMA updates in 2025–2026 are especially relevant).