Refusal to Accept Your Durg or Biologic Submission - Did You Know?

Did You Know?

Regulatory authorities globally are moving to require the electronic Common Technical Document (eCTD format) for all stages of submission - during clinical development, for marketing applications, and for post-marketing amendments and supplements. The US FDA has required eCTD format for electronic submissions since January 1, 2008. The European Medicines Agency (EMEA) will require all centralized applications in eCTD format beginning January 1, 2010. eCTD is accepted by more that 30 countries globally.

The eCTD format significantly cuts the cost and time of handling paper submissions, which can be equivalent to a semi-tractor full of paper, for regulatory authorities. It is the preferred format for regulatory reviewers in agencies in Europe, North America, and Asia. However, the eCTD format requires that the content be provided in fully-navigable Adobe Portable Document File (PDF) format to facilitate reviewer access to the content. This means that the document must have a hyperlinked table of contents, must contain bookmarks that are equivalent to the table of contents, and must contain hyperlinks to all content not located on the page of reference.

About Sage Templates and MasterControl Solutions

The Sage Templates enable Microsoft Word to be used to author documents for eCTD submissions, which are then converted to compliant PDF files by the MasterControl rendition server. The combination of Sage Templates and Master Control document management technology ensure that the correct files are available for submission publishing systems and are already compliant with agency requirements for navigation aides. Sage Templates contain MS Word files for all forms of document granularity required for eCTD submissions. Sage Templates include toolbars with buttons to help the authors insert the correct styles that convert to hyperlinked tables of content and equivalent bookmarks. Sage Templates include buttons for formatting different page layouts, to create bulleted and numbered lists, for inserting and formatting tables, for inserting cross-references that convert to PDF hyperlinks.

The use of Sage Templates with MasterControl Documents™ builds compliance into the authoring process and assures that compilation of the eCTD submission will be a streamlined process that is vastly faster and less expensive than the traditional paper submission assembly process.

For more information on Sage Templates, please contact a MasterControl representative, log onto or call Antoinette Azevedo at 866-434-6519.

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