04 · SUBM · HERMES · WORKBENCH
Submission · 7 jurisdictional dossiers
PMDA filed 17 May · 6 dossiers staged on reliance pathway
Agent reasoning trace · HERMES
PMDA dossier assembled · 312pp + 84pp annexdrna…1102
16 May 18:10 KSTValidators run · format + completeness passdrna…1140
17 May 11:50 KSTPMDA dossier filed · human sign-off S. Chen7f3b…91d4
17 May 14:22 KSTDossier assembly status · 7 jurisdictions
PMDA · JPFILED · 17 May 14:22
HSA · SGSTAGED · gated on PMDA
TGA · AUSTAGED · gated on PMDA
TFDA · TWSTAGED · gated on PMDA
KFDA · KRSTAGED · independent
NMPA · CNPRE-CT · local trial 4/18
HKSTAGED · reliance
Validators
FORMAT CHECKPASS · PMDA Class III
COMPLETENESSPASS · all required annexes
RECEIPT-CHAIN INTEGRITYVALID
Submission gates
CERv17 locked · 312 pp
IFUEN + JA executable
Risk filev4 · ISO 14971
PMCF plan3-yr · 455 patients
Governance
Receipt chain
PMDA dossier filed7f3b…91d4
Validators rundrna…1140
Human sign-offs
Sarah Chen · PMDA file17 May · ✓
Framework parity
PMDAHSATGATFDAKFDAPOL-RECEIPT-V1