CTD Mapping and the eCTD TOC

The first step in planning a CMC submission is to map the source documents to each section of the eCTD Module 3. This is done according to the ICH M4Q guidance, and, for U.S. submissions, FDA’s eCTD TOC (Table of Contents). It is recommended to do this process early on, as early as 12 months before the NDA filing, to make sure that all components are understood and assigned, and for ready gap analysis. Project management uses this eCTD TOC in the global project timeline and tracking tasks to support the CMC filing.

CMC submissions draw from many sources of information and data to produce eCTD submission documents:
• Development reports: characterization reports, formulation development, etc
• GMP Documents: specifications, procedures, validation reports, stability reports, etc.
• Databases: Batch analysis, stability, etc.
• Data sheets (LIMS): Chromatograms, spectra, etc.
• Documents from CMOs, suppliers, testing labs

An effective eCTD Map is a spreadsheet with the following columns :
1. eCTD section, according to the chosen granularity
2. Source documents needed to prepare the eCTD section other sections of the eCTD that are dependencies for this section
3. Who is responsible for each section
4. Key issues and action items, that are important for tracking by the CMC group and project management
5. Regional-specific issues, as relevant
6. Timing of key source documents and data (to be linked with the project management timeline)
7. Timing of draft 1, draft 2, final draft, final pdf, and eCTD QC

It is my experience that sponsors who start with this mapping process, bringing in the full CMC team early to make important decisions, will be at a distinct advantage in the overall planning and efficiency of submission preparation. Project management and upper management will be on board early to understand the overview of the components, who they are assigned to, and any key issues of content or timing.

CTD Quality Consulting would be happy to show you an example of a CTD map and provide you with a complimentary call to discuss and determine areas of improvement for your submission planning and preparation.

- Dr. Michelle Herrera Foster, CTD Quality Consulting, 978-356-0872