In March 2010, Health Canada began the Non-eCTD Hybrid Pilot as a
transitory aid for sponsors not yet ready to submit in eCTD format. A
regulatory activity in Non-eCTD Hybrid format is a full electronic
regulatory activity that is accompanied by Modules 1 and 2 in
paper-based format. This interim provision allowed Health Canada to
reduce the amount of paper being received and enabled review of the
regulatory activity in electronic format.
Health Canada believes that sufficient time has been provided
to facilitate transition to eCTD format. In addition, processing of
the Non-eCTD Hybrid format has increased the time of handling and
validation of regulatory activities in this format relative to
regulatory activities in eCTD format. For these reasons, 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.
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