Where Fast and Easy Meets Compliant

Top Resources for Industry Guidance

Many global agencies have mandated the eCTD as their preferred format. To confirm compliance with global regulations, it's important that you have a clear understanding of agency status and current guidances worldwide.

The table below shows the status of eCTD and NeeS (non-eCTD electronic submission) at health authorities around the world.

eCTD Status with Global Health Authorities
Authority
Status of eCTD
Status of NeeS
Requirement for Paper
FDA
Accepted
(eNDA) accepted only with approved waiver
None
EMA
Accepted
Accepted until end of 2009
None
Various EU authorities
Some HAs accept, and some even mandate (Czech Republic, Netherlands)
Per authority; many accept
Per authority; some require until end of 2009. Up to 15 of 32 HAs will not meet the mandate to accept electronic only by end of 2009. Some require full paper and some partial paper. Most require at least forms and cover letters.
SwissMedic
January 2010
Not accepted
None as of January 2010 except for specific documents called out in their Guidance for Industry (those requiring signatures)
Health Canada
In Pilot; no final date published
Not accepted
Paper still required for both co-submissions (full dossier) and hybrid submissions (partial)
PMDA
Accepted
Not accepted
May still be required
TGA
January 2010
Unclear
May still be required
ASEAN
No published plan
Some HAs will accept some documents electronically.
Still required