Release of Draft (Step 2) ICH Guidance: M7 Addendum - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk – July 2015

Notice to the reader:

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


July 30, 2015
Our file number: 15-108729-464

The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the Health Canada website for information and comment in accordance with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

Please note that draft guidance documents are only made available in English until finalized by the ICH.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 90 days in order to allow sufficient time for their assessment and subsequent transmission to the ICH.

Comments should be directed 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

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