26 June 2012

1) Health Canada announced the finalization of the “Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format


1      Health Canada announced the finalization of the “Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format”

Notable point: HealthCanda said in a statement in April 212, “Health Canada is considering ending the Non-eCTD Hybrid Pilot at the end of March 2013 and would like to encourage sponsors to transition to the eCTD format as soon as possible to expedite the elimination of paper from the regulatory review process,”

In June 2012 Health Canada announced that the new Module 1 of the CTD will not be accepted in electronic form until fall 2012, there is no any detailed information about the full transition of eCTD.

To find more information please use the below mentioned weblink

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