The Rise of eCTD: A Visual Explainer
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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.
The Rise of eCTD: A Visual Explainer
- 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