November 17, 2006

NOTICE

Our file number: 06-126231-883

Release of Draft (Step 2) ICH¹ Guidance:Pharmacogenomics - ICH Topic E15

The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the Health Canada Website² for information and comment in accordance with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Please note that draft guidance documents are only made available in English until finalized by the ICH.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 January 22, 2007 in order to allow sufficient time for their assessment and subsequent transmission to the ICH.

Comments should be directed to:

Phone: (613) 954-5706
Fax: (613) 946-0639
E-mail: agnes_v_klein@hc-sc.gc.ca

1 International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use

2 As a PDF file format under Applications & Submissions\Guidance Documents\ICH\Draft Guidelines Out for Comment