The document outlines the development and adoption of the electronic common technical document (eCTD) format from 1999 to 2018, detailing its mandatory use by various health authorities like the FDA, Health Canada, and the EMEA for drug submissions. It highlights the increasing percentage of submissions in eCTD format and the deadlines set for various types of applications, including NDAs and BLAs. By 2018, eCTD format became the standard for regulatory submissions across multiple countries.

1. THE RISE OF THE
eCTD FORMATThe Rise of the Electronic Common Technical Document Format
1999
2004
2005
2008
2009
FDA required submission of
electronic case report
tabulation (CRTs) & case report
forms (CRFs) in electronic
format for new drug and new
biological license applications
(NDAs and BLAs)
Health Canada begins accepting
submissions in eCTD & the
Japanese Ministry of Health
Labor and Welfare (MHLW)
begins accepting submissions
in eCTD format
FDA CDER requires package
inserts to be submitted in
electronic structure product
labeling (SPL) format
The FDA CDER requires electronic
submissions to be presented in
the eCTD format
The European Medicines
Evaluation Agency (EMEA) requires
marketing authorization
applications (MAA) to be
submitted electronically.
The FDA requires the content of
the Drug Establishment and Drug
Registration forms to be
submitted electronically.
1,000,000
3,100,000
2011
2015
Submissions Processed by FDA through the
Submissions Gateway
2.3
70
85
100
2006
2011
2015
2017
% of NDAs Submitted in eCTD format to
the FDA
% of New NDA Submissions in eCTD Format
to the FDA
70% 100%
2011 2015
% of New IND Submissions in eCTD Format
to the FDA
41% 80%
2011 2015
2010
The EMEA requires all agencies
participating in the centralized
procedure for MAAs to begin
submitting in eCTD format
2016
The EMEA requires all agencies
participating in the centralized
procedure for MAAs to begin
submitting in eCTD format as of
January 10
2017
As of May 5th, NDAs, ANDAs,
and BLAs must be submitted to
the FDA in eCTD format.
In April of 2017 the FDA then
extends deadline for
electronically submitting DMFs
and BPFs in eCTD format to
May 5th 2018
2018
As of January 1st, NDS, SNDS,
and ANDS must be submitted
to health Canada in eCTD.
As of May 5th, INDs and Master
Files must be submitted
electronically to FDA in eCTD
format.
84.0 %
16.0 %
eCTD
Other Format
% of Regulatory Activity Submissions to
Health Canada in eCTD format in 2016
0 25 50 75 100
Countries accepting eCTD
Countries Accepting Regulatory Submissions in eCTD format
- Thomson Reuteurs: http://ip-science.thomsonreuters.com/m/pdfs/implement-status-ctd-ectd.pdf
- The eCTD Summit: http://theectdsummit.com/
- PMDA: http://www.jpma.or.jp/information/ich/explanation/pdf/01_ich150309.pdf
- Health Canada: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/ectd-mandatory-notice-avis-obligatoire-eng.php
- EMA: http://esubmission.ema.europa.eu/ectd/
- FDA: https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm153574.htm
Australia
Canada
China
Croatia
Japan
Saudi Arabia
Singapore
South Africa
Switzerland
US
All EU/EEA Member States