Release of Draft (Step 2) International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: E2C(R2): Periodic Benefit Risk Evaluation Reports

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the Health Canada website for information and comment in accordance with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 March 9, 2012 until May 23, 2012. Please select and read through the link below titled "consultation document". Once read, please submit your comments via email, fax or by mail to:

Vicky Hogan
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
200 Tunney's Pasture Driveway, Address Locator 0700E
Ottawa, Ontario
K1A 0K9

Email: vicky.hogan@hc-sc.gc.ca
Telephone: 613-960-7211
Fax: 613-952-7738

Consultation Document

Interested parties are encouraged to provide comments and suggestions by May 23, 2012.

Reporting to Canadians

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

If you have any questions, contact Vicky Hogan.