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 and v4.0
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
- DSUR – Development Safety Update Report
Process to be followed to make a Health Canada eCTD submission
- 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 faced in making a Health Canada eCTD 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
- Life cycle 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
