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

Notice

March 16, 2015

Our File Number: 15-102878-816

 Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for 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The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted to the  ICH website for information and comment in accordance with Step 2 of the ICH process.

Please note that draft guidance documents are only made available in English until finalized by the ICH.  It is also important to note that amendments to draft documents may occur as a result of regulatory consultations and subsequent deliberations within the ICH.

All comments forwarded to Health Canada will be transmitted to the ICH as is, with the disclaimer that they are provided for information and do not necessarily represent the views of Health Canada, except as specifically indicated in separate comments.

As appropriate, your organization may alternatively wish to provide comments to your affiliate association in the U.S., Europe or Japan for their input directly to ICH.

Comments provided to Health Canada should be submitted no later than 60 days in order to allow sufficient time for their assessment and subsequent transmission to the ICH.

Comments should be directed 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

Email: HPFB_ICH_DGPSA@hc-sc.gc.ca
Telephone: 613-325-1754
Fax: 613-948-6818