Draft guidance document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format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