Release of Draft (Step 2) ICH Guidance: M4E(R2): Enhancing the Format and Structure of Benefit-Risk Information in ICH

August 19, 2015
Our file number: 15-109326-917

The above referenced draft guidance was released by the ICH^{Footnote 1} Steering Committee for consultation and is being posted on the  ICH website for information and comment in accordance with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.

Please note that draft guidance documents are only made available in English until finalised by the ICH.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 United States, 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:

Kader Kourad
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

E-mail: kader.kourad@hc-sc.gc.ca
Telephone: 613-793-6103
Facsimile: 613-946-0639