The use of hypertext links in eCTD submissions to aid navigation within and between PDF documents is commonplace. Along with the use of bookmarks, links can play a vital role in accelerating and facilitating the eCTD review process. Whilst an eCTD will not necessarily fail technical validation if hyperlinks aren’t created correctly, validation tools should still show errors where this is the case, reporting a failure to comply with eCTD best practice rules.
eCTD Validation Criteria v3.0 (which will come into force September of this year) states that:
“The applicant should make every effort to address these areas [failure to comply with best practice criteria] before the eCTD is submitted to the agency. The applicant should be prepared to include justification for any Best Practice criteria not met in the submission cover letter/reviewer's guide.”
The best practice criteria address some of the link formatting issues which any eCTD publisher will face. These will be addressed in the sections which follow.
When to link
The use of links within and between documents submitted in eCTD format is an important consideration for any submission publisher. There is no absolute rule set in stone which determines how many links should be created in any document, but the eCTD spec. v3.2.2 states that:
“Hypertext links throughout the document to support annotations, related sections, references, appendices, tables, or figures that are not located on the same page are helpful and improve navigation efficiency.”
The purpose of hypertext links, then, is to help the reviewer navigate through and between documents, and so this should always be in the mind of the publisher. Links to sections on the same page, for example, might not help the reviewer at all, and so such linking is merely an unnecessary waste of time.
For More Information click here: Apex Regulatory's Blog : PDF Hyperlinking within the eCTD
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