eCTD 4.0 Normalization Rules
Normalization is the process of revising folder and file names to ensure it complies with the eCTD and regional requirements.
| Attribute | Description |
| Subcategory | The Assembly low-level category. The available options depend on the Category selected. |
| Updated Submitted Available | Indicates if the submitted view has been updated since the current working assembly was created. |
Normalization rules for different assembly types.
Note: As a general recommendation, the following symbols must be avoided in file names and path to prevent undefined system issues: for \ / " ` < > : # & $ +.
| eCTD 4.0 Assembly Type | Rule | Examples |
| eCTD | When the assembly type is set to eCTD all paths are normalized during publishing. | N/A |
| eCTD allows a-z, 0-9, and -.. Other symbols are removed or changed with exceptions listed below. | ||
| Spaces, periods and underscores are converted to hyphens during publishing. | ||
| CN eCTD | CN eCTD allows a-z, 0-9, _, and - . Other symbols are removed or changed with exceptions listed below. | N/A |
| US eCTD | When set to US eCTD, all folder names, file names, and paths are normalized during publishing. However, capital letters and underscores are not replaced. | N/A |
| US eCTD allows a-z, A-Z, 0-9, _, and - . Other symbols are removed or changed with exceptions listed below. | ||
| Spaces and periods are converted to hyphens during publishing. |
| eCTD 4.0 Assembly Type | Rule | Examples |
| Standard | When set to Standard, all paths are based on the entries for the output folder and file. | N/A |
| Standard allows a-z, A-Z, 0-9, _, -, ., and spaces . Other symbols are removed or changed with exceptions listed below. | ||
| Periods are removed from the end of the value during publishing for (applies only for Folders). See example. | folder1../folder2./file.pdf --> folder1/folder2/file.pdf. | |
| Spaces are removed from the beginning and the end of the value during publishing (should be applies only for Folders). See example. | / folder1 / folder2 / file.pdf -->folder1/folder2/ file.pdf | |
| eCTD, CN eCTD |
— Uppercase letters are converted to lowercase during publishing. — Spaces and periods are converted to hyphens during publishing. |
N/A |
| CN eCTD, US eCTD | Multiple underscores in the value are replaced with one underscore during publishing. See examples. |
Multiple underscores examples: — CN eCTD : Out_put__File___Name.pdf--> out_put_file_name.pdf. — US eCTD : Out_put__File___Name.pdf -- > Out_put_File_Name.pdf |
| eCTD 4.0 Assembly Type | Rule | Examples |
| eCTD, CN eCTD, US eCTD | Multiple hyphens in the value are replaced with one hyphen during publishing. See examples. |
Multiple hyphens examples: — eCTD: Out-put--File--Name.pdf --> out-put-filename.pdf . — CN eCTD : Out-put--File--Name.pdf --> out-put-filename.pdf . — US eCTD :Out-put--File--Name.pdf --> Out-put-FileName.pdf. |
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— Spaces, underscores and periods are removed from the beginning and the end of the value during publishing. — The file extensions are kept if extension is present after publishing. — Two periods and more in line are not present in the resulting value after publishing. Periods are converted to hyphens. See examples. |
Periods rule examples: — eCTD:..Out.put.File...Name .......pdf --> out-put-filename.pdf. — CN eCTD: ..Out.put.File...Name .......pdf --> out-put-filename.pdf. — US eCTD: ..Out.put.File...Name .......pdf --> Out-putFile-Name.pdf |
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| eCTD, CN eCTD, US eCTD, Standard. |
The following symbols are removed from resulting value after publishing: [^<|:\">*?] `~!@#%^&*()+=<> . |
N/A |