When working with Chinese regulatory submissions, Submissions Publishing allows you to generate CN eCTD XSD 1.0 compliant XMLs for submission to the National Medical Products Administration (NMPA). Vault can validate these submissions in accordance with the CN NMPA 1.0 Validation Criteria Version.

Creating Content Plan Templates for Chinese Submissions

When you create a content plan template for Chinese submissions, you can use the Language for Submission, Lead Market Country, and Region fields to ensure that the content plan sections include content plan items for both Chinese language documents and foreign reference materials.

To do this, follow the instructions to create a content plan template.

When you create Content Plan Item Template records, populate the Region and Lead Market Country fields to specify that these records only apply to Chinese submissions. This will ensure that the content plan contains content plan items that are specific to the region or lead market of the submission.

About Foreign Reference Materials

If your submission includes any documents that have been translated to Chinese, you must also include the original document. These documents are called Foreign Reference Materials. As you compile Chinese submissions, ensure that the Language for Submission field is set on any Content Plan Item records matched to foreign reference material documents. Note that updating the Language field on any published Content Plan Item records triggers continuous publishing, if enabled.

About Node Extensions & Study Tagging Files

The Chinese eCTD specification supports Study Tagging Files (STFs) and allows node extension use for biologics within Section 3.2.R.

Viewing & Managing Submission Administrative Information

Vault supports viewing and managing Submission Administrative Information for CN 1.0 XSDs. See Managing Submission Administrative Information for details.