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

• On 01 January 2019 the new SWISSmedic update Module 1 Specification for eCTD v1.4 is implemented.
• Both versions (v1.3 and v1.4) will be valid for a half-year period from 01 January 2019 to 30 June 2019.
• As from 01 July 2019 the Swiss Module 1 Specification for eCTD v1.4 must be used for all eCTD submissions.

FDA has updated the guideline for Specifications for eCTD Validation Criteria (V3.8). In this version FDA updated;

• Descriptions of the eCTD Validation Criteria of Error Codes 1734, 1735, and 1736 which support the Study Data Technical Conformance Guide

Again, FDA has updated the Providing Regulatory Submissions in Electronic Format guideline. Now, the requirement to submit DMF Type III (Packaging Material) electronically (in eCTD format only) become effective 60 months after May 5, 2015 (May 5, 2020).

For DMF Type III, applicant must electronically submit any amendments, supplements, and reports,

These Validation rules build on the information provided in Preparation of Regulatory Activities in “Non-eCTD Electronic-Only” format guideline.

The revised rules assist stakeholders in the preparation of regulatory transactions in Non-eCTD format.

It is important for sponsors to ensure that the validation rules are followed accurately in order to avoid encountering validation errors.

Health Canada has updated the timeline for Mandatory Use of eCTD Format for Types of Regulatory Activity.

From since 2004, Health Canada is accepting regulatory activities in eCTD format. As of December 2018, 93 percent of regulatory activities (Part C, Division 8 of the Food and Drug Regulations, for human drugs) have been submitted in eCTD format.

• Singapore HAS (Health Sciences Authority) plans to commence the development phase in 2019 in order to allow eCTD submissions by the end of 2020.
• eCTD will start with new original marketing applications (NDAs and GDAs).
• eCTD submissions will be voluntary during the initial implementation period. The requirement for mandatory submissions will be reviewed at a later date.

FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4.

Summary of Changes for Version 2.4

Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below:

1. ‘REMS Supplement’ added in Submission Types and Description of Use Table
2. ‘REMS Supplement’ added as valid submission type for PAS and CBE-30 in Supplement-Effective-Date-Types and Descriptions of Use Table
3. ‘REMS Supplement’ added as valid submission type for submission sub-types of ‘application’,