Annotated eCTD Templates

The use of CTD/eCTD templates is a proven efficiency in the authoring of eCTD documents, whether it is a paper or electronic submission. The use of the templates assures consistent formatting and prevents the previously-common situation where the publishing group was burdened with having to reformat all of the documents because the authors did not meet the publishing standards. This inefficiency can delay the submission timeline significantly, and this is something that can and should be prevented.

The eCTD templates can be purchased or created by the sponsor, and they must follow a fixed style guide with company-approved headers/footers and headings that match eCTD specifications. It is highly useful, even to the experienced submission author, to provide annotations in the templates (or accompanying the templates in a separate document) that specify the content required in each section of the eCTD. Some purchased eCTD templates do provide annotations that reflect ICH guidance and perhaps some additional information.

It is important to note that no generic set of eCTD templates can provide all of the important information that authors need to include in each section of the eCTD. This is because every submission is product-dependent and region-dependent. This is particularly true with CMC submissions. Annotations should be reviewed and approved by the CMC submission team and management to avoid endless-loop reviews of submission components later on.

It is recommended that, in addition to formatting requirements, template annotations address the following:

• Directions for granularity; ideally each template should be a granular section of the eCTD from the start.
• Product-specific information, addressing ICH guidance
• Regional-specific information, addressing regional agency guidance
• Agreements and commitments from agency meetings and previous filings
• Definitions of acronyms and abbreviations, for consistency throughout the submission
• Instructions to put hyperlinks in blue text, since authors are responsible for letting publishing know which section is to be cross-referenced

Sponsors often have separate templates for IND and NDA applications. It is possible to have a master set of eCTD templates that address what information must be added or expanded throughout development, from phase 1 to phase 2 to phase 3 to NDA/BLA. This generic set would be customized for each product and granularity for life cycle management at the time of submission planning.

The level of detail in Module 3 increases in most sections of the submission, from IND to NDA. For example, IND 3.2.S.2.2 Description of Manufacturing Process for a small molecule with a standard manufacturing process may include only a detailed flow chart. By phase 2 additional details would be provided, and by phase 3 the level of detail would be nearing that of the NDA.

CTD Quality Consulting would be happy to discuss your eCTD template needs with you, and assist you in customizing your annotations, to enhance the efficiency of your submission process.

- Dr. Michelle Herrera Foster, CTD Quality Consulting, michelle@ctdquality.com, 978-356-0872