Why you should buy this report

This report is a single point solution to study all the recent Regulatory changes/ updates with respect to the USFDA and Health Canada Module 1, Validation, and respective changes.

Summary

• The new module eCTD standards, Validation and Module 1 DTD changes updates with respect to USFDA to help clients in line with Regulatory changes for their submission.
• Various version changes for validation requirements in changes of new rules for US FDA.
• The update about changes in Validation rules implemented in Health Canada.
• The updates about accept of REP XML based application form and implementing REP XML validation in Health Canada.

Table of Contents

1. US FDA
   1. New Module 1 eCTD standards
   2. CTOC 2.3.3 (Comprehensive table of contents)
   3. REMS Grouping and header update in stylesheet
   4. US FDA Validation Update version 3.9
   5. US FDA Validation Update version 4.0
   6. US FDA Validation Update version 4.1
   7. US FDA Validation Update version 4.2 (Newly updated very recent)
2. Health Canada (CA)
   1. Validation rules for regulatory transactions provided to Health Canada in the electronic common technical document format
   2. Health Canada - 3011 form
   3. Validation Rules for Transactions Containing the Regulatory Enrolment Process (REP) Company XML File