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Drugs and Health Products

Release of Draft (Step 2) ICH Guidance Document: E18: Genomic Sampling and Management of Genomic Data

The above referenced draft guidance was released by the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Steering Committee for consultation and is being posted on the ICH 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 January 8, 2016 until April 7, 2016. Please select and read through the link below titled "consultation document". Once read, please submit your comments via email, fax or by mail to:

Dr. Agnes Klein
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Biologics & Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
100 Eglantine Driveway, Tunney's Pasture
Ottawa, Ontario
K1A 0K9

Telephone: 613-954-5706
Facsimile: 613-946-0639

Consultation Document

Interested parties are encouraged to provide comments and suggestions by April 7, 2016.

Reporting to Canadians

Health Canada will make the results of this consultation available on this web site.
If you have any questions, contact Dr. Agnes Klein.

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