Release of Draft (Step 2) International Council on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E6 Integrated Addendum: Good Clinical Practice

Notice to the reader:

The online consultation is now closed.

The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the Health Canada website for information and comment in accordance with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 November 25, 2015 until February 1, 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:

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

E-mail: norman.viner@hc-sc.gc.ca
Telephone: 613-293-1962
Facsimile: 613-952-2816

Interested parties are encouraged to provide comments and suggestions by February 1, 2016.

Reporting to Canadians

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

If you have any questions, contact norman.viner@hc-sc.gc.ca.

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