North America

Country: The USA
Health Authority: US Food & Drug Administration (USFDA)
eCTD, Accepted Since: May 5, 2017
eCTD Version: Module 1 Specification v2.5 and DTD v3.3, M2-M5 – v3.2.2 and v4.0

Types of Applications

IND, NDA, ANDA, BLA, DMF, Structured Product Labeling (SPL) Submissions, Originals, Amendments, Annual report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), eCTD baseline Submissions, eCTD Submissions for lifecycle management (LCM)

Process to be followed to make an eCTD FDA submission

  • Learn about the eCTD requirements
  • Review the eCTD submission resources
  • Submit fillable forms and compliant PDFs
  • Request an application number
  • Send a sample submission to the FDA
  • Submit via the electronic submission gateway: Industry electronic submissions gateway

Challenges faced in making an eCTD FDA submission

  • Requires cutting-edge technology and seasoned staff
  • Not all the content is in a standard format. Hence standardization is required
  • Difficult to implement last minute changes
  • Local affiliates have limited access to create or customize
  • Baseline submissions are costly and likely to be of limited value
  • Lifecycle management
  • Consolidated approach to drafting of dossier

Mandatory Deadlines to make an eCTD FDA submission

Electronic submission of standardized study data for NDA, BLA, ANDA,
and Commercial IND - September 15, 2021

How can Freyr help?

  • Guarantee your ROI with an eCTD software that optimizes cost-per-submission
  • Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
  • eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment For more information on the same, consult us

Other Countries

EU, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN