08.12.2010

CA: Health Canada updates Q&A for the preparation of eCTD submissions

Health Canada has released an updated version of their "Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the Electronic Common Technical Document (eCTD) Format". As usual the updated Q&A are available directly on the Health Canada website and as downloadable PDF-file.

Revisions have been introduced in the updated Q&A for 14 Questions, whereas 2 Questions (Q#5 and Q#20) concerning previous submission formats were completely withdrawn. These changes are in principle reflecting the further progress of the eCTD implementation at Health Canada as the previous "co-submission" filing format is no longer accepted since January 1^st, 2010 and some submission types are even accepted electronic-only since August, 2010.

New Questions #26 - 36 were introduced giving further guidance on the eCTD requirements. The more prominent changes include:

Q26: External hyperlinks to certain websites (e.g. sponsor`s own website) or to e-Mail addresses are now accepted. Note: Any external links to information pertinent to the review process will still result in a validation failure
Q30: Health Canada now accepts PDF 1.7 files
Q31: Non-eCTD hybrid filing format is requested in case a valid eCTD cannot be provided by an applicant
Q33: The MD5-checksum file (index-md-5.txt) is no longer required in printed version as annex to the cover letter
Q35: Clarification on how to present information about submission fees is provided
Q36: Clarification on how to provided Drug Master Files in eCTD format is provided

For detailed information, please see the updated Q&A.

[Source: Health Canada website]

Links:

www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/qa_qr_guide_ectd-eng.php

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