Section (Node) Extensions are a provision for extending the CTD Table of Contents to a lower level than defined by the regulatory authorities. They will be shown as extra headings in the CTD Table of Contents.
In general, Section (Node) Extensions should be added only at the lowest level of the TOC. For example, you can extend the Section 2.3.R Regional Information but not the 2.3 Quality Overall Summary section since the latter is not the lowest element defined in the eCTD TOC.
Note: In Europe and Canada, Section (Node) Extensions are recommended for additional granularity (Reference 7 supplies a number of guidelines on the use of Section (Node) Extensions for EMEA sequences). In the US, the use of Section (Node) Extensions is strongly discouraged and should be avoided unless agreed in advance with the FDA.
Note: PUBLISH’s repeatable section capability to organize studies can also be used for EMEA and Health Canada. PUBLISH will automatically generate compliant Section (Node) Extensions when sequences are published.
See the following sections for additional information:
Adding a Section or Node Extension
Modifying a Section or Node Extension
Removing a Section (Node) Extension
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