A CTD Dossier is the standardized format used for the registration and approval of pharmaceutical products with regulatory authorities such as Drug Regulatory Authority of Pakistan, World Health Organization, and other international agencies.
It provides comprehensive information about a pharmaceutical product's quality, safety, and efficacy to support its registration and marketing authorization.
CTD Structure
The CTD is divided into 5 Modules:
Module 1 – Administrative & Regional Information
Contains country-specific administrative documents.
Typical Contents:
Application Form
Cover Letter
Manufacturing License
GMP Certificate
Free Sale Certificate (if applicable)
Authorization Letters
Product Labels & Packaging Artwork
Product Registration Certificates
Applicant Information
Module 2 – CTD Summaries
Provides summaries of Modules 3, 4, and 5.
Contents:
Quality Overall Summary (QOS)
Non-Clinical Overview
Non-Clinical Written Summaries
Clinical Overview
Clinical Summary
Module 3 – Quality Documentation
This is the most important module for pharmaceutical manufacturers.
Drug Substance (API)
API Manufacturer Details
Manufacturing Pro