Health Canada Looking to Transition all Submissions to eCTD Format

Posted 27 April 2012 By Alexander Gaffney

Health Canada is announcing its intent to shut down a pilot project currently used by sponsors who still wish to submit common technical documents (CTDs) in their physical format instead of the now-common electronic CTD (eCTD) format.

Health Canada's pilot project, which involves the sponsor filling out CTDs in electronic format and submitting them in their physical form to Health Canada, was intended to be a "transitory aid for sponsors not yet ready to submit in eCTD format," and launched in March 2010.

In a statement, Health Canada said it "believes that sufficient time has been provided to facilitate transition to eCTD format," and the pilot program has now become a burden on the resource-deprived agency.

"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," the agency said in a statement.

Health Canada is recommending sponsors currently enrolled in the pilot program look at the feasibility of transitioning to a fully eCTD-based system, and also recommended several options for sponsors who do not feel comfortable doing so yet, including hiring external contractors, using online tools or using stand-alone software.

The document only applies to sponsors of pharmaceutical products.


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Health Canada - Non-electronic Common Technical Document (eCTD) Hybrid Pilot

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Tags: Electronic Common Technical Document, Submissions, CTD, DOssier, Latest News, pharmaceutical, eCTD, drug

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