EU Telematics PIM � _





Human eSubmission
eCTD v3.2
eCTD EU M1 specification

Veterinary eSubmission
eSubmission expert group

eSubmission expert group documents


External Links



Common Repository


CESP Portal
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PSUR Repository

Industry access

NCA access


eCTD v4.0


Paediatric submissions




The materials published on are documents produced and/or adopted by the eSubmission Experts Group . They are published for consultation with interested parties and may be removed, updated or replaced at any time. Documents related to eCTD that have been adopted by other regulatory instances may be removed from this site, and only links to their actual location will be maintained (e.g. eCTD standards on the Notice to Applicants web site). It is inappropriate to use any working drafts published on this site as reference material or to cite them other than work in progress .

EMA is a member of the eSubmission Expert Group and is hosting this working page but it is not responsible for its content.




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