Notice: Release of Draft (Step 2) ICH Guidance: M7 Addendum - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Notice to the reader:

The online consultation is now closed. The final guidance is available now.

The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the Health Canada website for information and comment in accordance with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 July 30 until October 28, 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:

Alisa Vespa
Bureau of Metabolism, Oncology and Reproductive Sciences
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott St, Holland Cross
Ottawa, Ontario

Telephone: 613-261-2997
Fax: 613-941-3694

Interested parties are encouraged to provide comments and suggestions by October 28, 2015.

Reporting to Canadians

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

If you have any questions, contact Alisa Vespa.

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