Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals on Human Use (ICH) Guidance: M8 - Electronic Common Technical Document: Implementation Guide

The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the Health Canada website for information and comment in accordance with Step 2 of the ICH process.

How to Get Involved

This consultation is open for comment starting March 16, 2015 until May 15, 2015. Please select and read through the link below titled "consultation document". Once read, please submit your comments via email, fax or by mail to:

Vikesh Srivastava
Business Informatics Division
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
250 Lanark Avenue, Graham Spry Building
Ottawa, Ontario  K1A0K9

Telephone: 613-325-1754
Fax: 613-948-6818

Consultation Document

Interested parties are encouraged to provide comments and suggestions by May 15, 2015.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact HPFB_ICH_DGPSA@hc-sc.gc.ca.