The International Conference on Harmonization recently published a new Specification for Submission Formats for eCTD document. The document achieved ICH step 4 classification, meaning it’s approved for use by all regions. Collapsing bookmarks when documents are opened, a requirement for unique headers or footers on all pages and a limited set of fonts that are recommended for embedding are among the most notable new rules.
Compound documents will not be part of the Regulated Product Submissions (RPS) standard. The decision was recently announced by the International Conference on Harmonisation’s (ICH) M8 working group which had been deliberating on a number of negative ballot comments registered in September 2013.
As many of you know, the FDA issues eCTD Guidance and Specifications to clarify implementation of regulations. In the currently posted specification concerning PDFs dated June 4, 2008, the official PDF version is 1.4, which is supported in Adobe Acrobat 5 and later. As new versions of the PDF specifications are released, they are evaluated for future acceptance. Therefore, the answer to the question “Which version of PDF can I submit?” changes as the PDF standards evolve.
The May 2011 ballot date was missed and is now delayed until September 2011. Why was the date missed? In my opinion, we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.
As adoption of the Common Technical Document and the eCTD has progressed through the regions, variations in the content and structure of the dossier/application requirements have emerged, making submissions regionally different. This slows the preparation of submission content and delivery, and lobbies against submission efficiency aiding a rapid health product development timeline. Harmonized submission content and structure are lofty goals that often never realistically and unilaterally enter the streamlined equation for product development.