Notice : Implementation of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E2F: Development Safety Update Report (DSUR)

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July 16, 2012

Our file number: 12-109267-34

Health Canada is an active participant in the ICH and is committed to the integration of ICH guidances, including the ICH E2F, in the framework of its drug regulatory functions.

Health Canada is currently determining how it will implement the new ICH E2F Guidance.  Upon completion of this exercise a Notice will be posted on Health Canada's website informing clinical trials sponsors of the implementation strategy.

The E2F Guidance from the ICH was developed to standardise the reporting of safety information for therapeutic products in development.  To date, the ICH E2F Guidance has been adopted and implemented by the regulatory bodies of the United States and the European Union.

Until the Notice on the ICH E2F implementation strategy is posted, we ask you to contact Hoda Eid if you are planning to submit a DSUR to Health Canada.

Hoda Eid, M.Sc., Ph.D.
Manager,
Adverse Drug Reaction Division
Office of Clinical Trials
Therapeutic Products Directorate

Telephone: 613-941-1622
Fax: 613-954-4474
E-mail: hoda.eid@hc-sc.gc.ca