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.
While effective immediately, the new ICH specifications won’t be enforced until regional agencies like the U.S. FDA update validation criteria. Regional health agencies would likely classify the new ICH requirements as mid-level errors or best practices.
Perhaps the most notable change is that bookmarks should be collapsed when documents are opened. This rule clarifies a practice that has been subject to interpretation and handled differently by regulatory professionals and eCTD software systems. For example, one preference is setting the document title as the top level bookmark and then opening bookmarks at a second level so that the table of contents (TOC) is displayed. The ICH weighing in gives all parties a uniform way to do things. Software tools that allow publishers to edit bookmarks in the system as opposed to pre-processing will be helpful in complying with the collapsed bookmarks requirement.
Submission publishing workloads will likely increase when enforcement of the unique header or footer requirement begins. The ICH specification states “The M4 Granularity document specifies that all pages of a document should include a unique header or footer that briefly identifies its subject matter.” To sufficiently meet this requirement, the header or footer should speak to the general subject matter of the document.
Finally, ICH included what amounts to best practices for embedding fonts. The specification document notes that regulatory authorities cannot guarantee the availability of fonts except Times New Roman, Arial, and Courier. Other fonts should be embedded to avoid formatting mishaps. Helpful techniques to limit storage space sacrificed to embedded fonts are as follows:
- Limiting the number of fonts used in each document
- Using only True Type or Adobe Type 1 fonts
- Avoiding customized fonts
Click here to read full text of the ICH eCTD specification document. For further explanation on planned implementation and enforcement of these specifications, sponsors should contact the individual regulatory authorities and/or eCTD software/services vendors.