TGA now accepting eCTD submissions

TGAThe TGA have now started accepting applications from the pharmaceutical industry in the format of electronic Common Technical Documents (eCTD). After their initial pilot program, they have an updated the version of the Australian eCTD Module 1 and Regional Specification – Version 3.0.

These specifications include the following recommendations for the formatting of the PDF documents to further aid the reviewer in the application evaluation:

  • Add Bookmarks and a Table of Contents to make it easier for the reviewer to navigate through the PDF document.
  • If the PDF document contains more than five pages, a Table of Contents should be included on the first page of the document.
  • Where appropriate, use Hyperlinks to further help with the evaluation of the application.
  • Bookmarks and Hyperlink must be relative and should have the magnification ‘Inherit Zoom’.
  • Bookmarks and Hyperlinks cannot be broken or inactive.

Debenu PDF Aerialist Pharma is a great tool to use to ensure your PDF documents meet all of these requirements. With automated processes, it significantly reduces the time needed to format PDF documents before adding them into an eCTD compiler.

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