These documents have been created/adopted by the eSubmission CMB or by the TIGes.
HMA eSubmission Roadmap
Annexes to the eSubmission Roadmap
EU Harmonised eCTD Guidance
EU Harmonised NeeS Guidance
EMA eSubmission Guidance for the Centralised Procedure
- All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website here.
Best Archiving Practice