Draft guidance document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format
From Health Canada
Current status: Closed
Opened on June 26, 2019 and will close to new input on August 26, 2019.
This is a technical document that provides instruction on how to implement the International Council for Harmonisation (ICH) Electronic Common Technical Document (eCTD) v4.0 specifications for Health Canada Module 1 submission content. This document is being published along with an accompanying notice, to solicit consultation from external stakeholders, for implementation planning purposes.
Join in: how to participate
Send an email to hc.ereview.sc@canada.ca with your ideas or comments to make yourself heard.
Who is the focus of this consultation
We will engage with:
- Pharmaceutical companies filing regulatory activities to Health Canada in eCTD format
- Consulting companies who assist pharmaceutical companies in preparing their eCTD transactions
- eCTD tool developers and tool vendors.
Key questions for discussion
Do stakeholders have any comments or concerns should Health Canada decide to implement eCTD v4.0?
Contact us
Email: hc.ereview.sc@canada.ca