Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: M7 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the Health Canada website for information and comment in accordance with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 February 25, 2013 until April 26, 2013. Please select and read through the link below titled "consultation document". Once read, please submit your comments via email, fax or by mail to:

Celia Lourenco
Office of Clinical Trials
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott St, Holland Cross
Ottawa, Ontario
K1A0K9

Telephone: 613-954-6494
Facsimile: 613-952-9656

Consultation Document

Interested parties are encouraged to provide comments and suggestions by April 26, 2013.

Reporting to Canadians

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

If you have any questions, contact Celia Lourenco.