Medical Writing Regulatory Writing Basics An overview of the Common Technical Document (CTD) regulatory dossier

Volume 23, Issue 2 - Regulatory Writing Basics

An overview of the Common Technical Document (CTD) regulatory dossier


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. 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 (pharmaceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (clinical trials). Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers.

Download the full article


  1. ICH M4 Guideline: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (R3) [cited 2004 Jan 13]. Available from:
  2. ICH M8 Guideline: Electronic Common Technical Document [cited 2010 Nov 8]. Available from:
  3. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals [updated 2013 Dec]. Available from:
  4. ICH M4 Guideline: General Questions & Answers Document (R3) [2004 Jun]. Available from:
  5. ICH M4Q Guideline: Quality Overall Summary of Module 2 and Module 3: Quality (R1) [cited 2002 Sep 12]. Available from:
  6. ICH M4Q Guideline: General Questions & Answers Document (R1) [cited 2003 Jul 17]. Available from:
  7. ICH M4S Guideline: Nonclinical Overview and Nonclinical Summaries of Module 2 and Module 4: Safety (R2) [cited 2002 Dec 20]. Available from:
  8. ICH M4S Guideline: General Questions & Answers Document (R4) [cited 2003 Nov 11]. Available from:
  9. ICH M4E Guideline: Clinical Overview and Clinical Summary of Module 2 and Module 5: Clinical Study Reports (R1) [cited 2002 Sep 12]. Available from:
  10. ICH M4E Guideline: General Questions & Answers Document (R4) [cited 2004 Jun 10]. Available from:



Regulatory writing basics
Message from the President
A guide to pre-approval regulatory documents
Effective authoring of clinical study reports: A companion guide
The clinical study protocol and medical writing: A good fit?
The Investigator's Brochure: A multidisciplinary document
An overview of the Common Technical Document (CTD) regulatory dossier
Good clinical practice (GCP): A universal call for ethics in biomedical research
Adverse event reporting: A brief overview of MedDRA
The approval process of medicines in Europe
Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One
The needs assessment in continuing medical education
Origin and development of English for Medical Purposes. Part II: Research on spoken medical English
Did minor flaws in a new drug reveal major flaws in company publication practices?
What every medical writer needs to know
Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy
In the Bookstores
Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making
Regulatory Writing: The essence of regulatory writing as defined by its jargon
Medical Communication
News from the EMA
English Grammar and Style: Points of view
The Webscout
Gained in Translation: Science at the multilingual crossroads
Out On Our Own
The Light Stuff


The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk