Four submission lanes. Four different readiness problems.
AMCP is guidance-aligned. EU JCA is PICO-driven. Germany is module-and-portal-driven. CDA-AMC is filing-and-packaging-driven. DossierDock keeps the working path stable while the checks, review threshold, and export logic change by lane.
Four submission lanes. Different constraints, one working path.
Templates, checks, and packaging gates vary by market. The working path does not.
AMCP
Guidance-aligned dossier
Active demo lane
EU JCA
PICO-based package
Structural readiness lane
AMNOG
Portal-safe export
Portal-safe export lane
CDA-AMC
SharePoint-safe filing
SharePoint-safe packaging lane
The current scope covers channel-specific structure, packaging, and export mechanics first. Operational maturity is not uniform across channels, and we keep that explicit in demos.
The lane logic changes underneath. The working path does not.
DossierDock does not treat these as four skins over one generic checklist. Each lane has its own template, checks, review threshold, and export assumptions because the submission mechanics are different in kind, not just in label.
AMCP
Channel logic
Guidance-aligned payer dossier
Main operational risk
Incomplete or inconsistent AMCP-style package, especially when teams mistake guidance for a fixed law-like checklist.
DossierDock role
Checklist mapping, N/A policy, file checks, references, guidance review, and governed export history.
EU JCA
Channel logic
PICO-driven clinical assessment package
Main operational risk
Missing PICO-linked evidence, Appendix D materials, search dates, or package expectations around the evidence set.
DossierDock role
PICO-aware structure, Appendix D buckets, RIS or full-text presence checks, search dates, and table checks.
Germany AMNOG
Channel logic
Module-driven dossier plus portal upload
Main operational risk
ZIP, path, size, wrapper, module-root, or supporting-document defects that break the upload path before the dossier is even reviewed.
DossierDock role
Portal-safe preflight, Modul 1 to Modul 5 export layout, rule-backed packaging checks, and module-root ZIP discipline.
CDA-AMC
Channel logic
Filing-driven reimbursement review package
Main operational risk
Missing templates, economic or BIA models, references, or SharePoint-incompatible filenames and ZIP structure.
DossierDock role
Required-file checks, economic or BIA model inclusion, RIS and reference expectations, and ZIP or path or filename validation.
Channel-specific checks are real. Channel acceptance claims are not.
DossierDock checks structure, packaging, and selected consistency mechanics. It does not certify scientific quality, reimbursement success, or reviewer acceptance for any lane.
DossierDock checks
Section completeness, N/A rationale, file openability, references, and guidance-alignment checks.
DossierDock does not claim
AMCP compliance, payer acceptance, or scientific persuasiveness.
DossierDock checks
PICO structure, Appendix D completeness, search dates, RIS or full-text presence, and packaging warnings.
DossierDock does not claim
Scientific validity of the assessment, correctness of PICOs, or HTA acceptance.
DossierDock checks
Modul 1 to Modul 5 ZIP structure, no wrapper folder, path or size or file checks, and required evidence-file packaging.
DossierDock does not claim
Additional benefit, comparator correctness, or G-BA or IQWiG acceptance.
DossierDock checks
Required templates or files, economic and BIA model presence, RIS files, and ZIP or path or filename constraints.
DossierDock does not claim
Pharmacoeconomic validity, reimbursement outcome, or CDA-AMC acceptance.
AMCP Format 5.0
Active demo lane.
Submission context
AMCP Format 5.0 is guidance-aligned, not a regulatory mandate. Payer and PBM intake requirements vary. DossierDock separates AMCP guidance checks from payer-specific intake mechanics, with room for organization-specific settings where needed.
What DossierDock validates
Required section completeness across all AMCP sections, with N/A handling for dossier types A/B/C. File openability and format checks. Password-protected PDF detection. Filename checks. Cross-section agreement for cutoff dates, primary endpoint names, and sample sizes. Table-structure checks where configured.
What DossierDock exports
Working, frozen-review, and submission ZIP exports with a package record, preflight report, and direct traceability downloads.
EU HTA JCA
Structural readiness lane. Deeper PICO/REA depth remains in progress.
Submission context
The EU Joint Clinical Assessment framework has a clear normative hierarchy. Annex I of Implementing Regulation (EU) 2024/1381 contains binding "shall" requirements. Annex 2 Technical Specifications and Guidance are non-binding. Their "should" conventions are advisory unless an organization tightens them with its own settings.
What DossierDock validates
Annex I structural requirements, treated as must-fix by default. Annex 2 hygiene checks: password-protected files, D.1 full texts as PDF, RIS reference list presence, watermark guidance, and PDF usability conventions, shown as warnings by default. Appendix D bucket organization (D.1–D.9). PICO scope registry and amendment bundle packaging remain available as secondary surfaces.
What DossierDock exports
Template-compliant package with clear run history for environment-specific EU HTA platform constraints.
Germany AMNOG
Portal-safe export lane. Live trial-upload evidence remains the proof step before any "portal-gate validated" claim.
Submission context
G-BA portal-facing documentation defines strict technical gates, including ZIP root structure, size limits, path-length caps, and file-security or character constraints. Live trial-upload evidence remains the proof step for edge behavior and any stronger portal-gate claims.
What DossierDock validates
Portal-facing preflight: ZIP root structure, size limits, path-length caps, invalid character detection, and dossier structure checks per Anlage II.1. Required PDFs, RIS placement, and ASCII program-code validation stay inside the same packaging review.
What DossierDock exports
Portal-aligned ZIP for the documented module-root, wrapper, and path or character constraints.
CDA-AMC
SharePoint-safe packaging lane. Deeper template-family coverage continues to expand.
Submission context
CDA-AMC reimbursement review submissions use a SharePoint channel with specific packaging constraints. CDA-AMC encompasses multiple template families across review phases. DossierDock models the submission channel constraints that are consistent across them.
What DossierDock validates
Decoded path length ≤ 400 characters. ZIP packaging enforcement. Multi-ZIP naming convention guidance. Filing window and access lead-time awareness.
What DossierDock exports
ZIP with SharePoint-compatible path constraints.
See channel-specific validation on your workflow.
We can walk through the lane that matters first, explain what the current checks do cover, and keep the non-claims explicit.