HEALTH CANADA eCTD

Health Canada

Country: Canada
Health Authority: Health Canada
eCTD, Accepted Since: May 14, 2015
eCTD Version: Module 1 Specification v2.2 and M2-M5 – v3.2.2

Types of Applications

  • NDS – New Drug Submission
  • SNDS – Supplement to a New Drug Submission
  • SNDS-C – Supplement to a New Drug Submission – Conditional
  • ANDS – Abbreviated New Drug Submission
  • SANDS -Supplement to an Abbreviated New Drug Submission
  • NC – Notifiable Change
  • CTA – Clinical Trial Application
  • CTA-A – Clinical Trial Application – Amendment
  • DINA – Drug Identification Number Application
  • DINB – Drug Identification Number – Biologics
  • PDC – Post DIN Change
  • PDC-B – Post DIN Change – Biologics
  • PSUR-C – Periodic Safety Update Report – Conditional
  • PSUR-PV – Periodic Safety Update Report – Pharmacovigilance
  • UD-PV – Undefined Data Pharmacovigilance
  • RMP-PV – Risk Management Plan – Pharmacovigilance
  • Level III – Post-Notice of Compliance Changes – Level III
  • YBPR – Yearly Biologic Product Report
  • MPNDS – Pre-NDS Meeting
  • MPSNDS – Pre-SNDS Meeting
  • MPNC – Pre-NC Meeting
  • MPDIN – Pre-DIN Meeting
  • PRECTA – Pre-Clinical Trial Application Meeting
  • PRNDS – Priority Request NDS
  • PRSNDS – Priority Request SNDS
  • PAND – Pandemic Application
  • DMF Type I – Drug Master File Type I
  • DMF Type II – Drug Master File Type II
  • DMF Type III – Drug Master File Type III
  • DMF Type IV – Drug Master File Type IV
  • EU NDS – Extraordinary Use New Drug Submission
  • EU SNDS – Extraordinary Use Supplement to a New Drug Submission
  • UDRA – Undefined Regulatory Activity
  • UDRA – Undefined Regulatory Activity
  • DSUR – Development Safety Update Report

Process

  • Hold technical pre-submission consultation
  • File eCTD sample
  • Verify eCTD sample
  • Obtain eCTD identifier
  • File Regulatory transaction in eCTD format
  • Verify Regulatory transaction in eCTD format
  • Distribute Regulatory transaction in eCTD format

Challenges

  • 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

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

USA, EU, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN

References