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An overview of the Common Technical Document

What is the purpose of CTD?
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States and beyond.
What is a CTD in medical writing?
CTDs are the application dossiers required for the registration of new medicines, and are the end-product of the clinical development process; they are the ultimate challenge in writing regulatory documentation.
The format and content of CTDs is set out in ICH M4.
What are the 5 modules of CTD?
Regulatory Consultant at Syneos Health
Regulatory Dossier:CTD (Common Technical Document):Module 1 - Administrative information:Module 2 - Quality overall summary:Module 3 - Quality:Module 4 - Non Clinical study reports:Module 5 - Clinical study reports:
The CTD dossier is divided into five main modules: Module 1 – Administrative information and prescribing information; Module 2 – Overviews and summaries of Modules 3–5; Module 3 – Quality (pharma- ceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product.

An overview of the Common Technical Document

What is the purpose of CTD?

What is a CTD in medical writing?

What are the 5 modules of CTD?

Regulatory Consultant at Syneos Health