In month of June 2020, USFDA updated header of Structured Product Labeling (SPL) XML:

• Updated xml-stylesheet reference
• Updated the schemaLocation of the urn:hl7-org:v3 namespace

    Error during the Pragmatic SPL Data Validation with old header:

1. There must be an xml-stylesheet reference to “https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl“.

World-wide Health Authorities continuously updating requirements and standards for electronic submission, so it much necessary to keep updated your self with current specifications to make eCTD submission 100% error free and compliant.

Current eCTD Module 1 Specification, DTD, and Validation Criteria Version with Update