Medical Writing Regulatory Writing Basics Regulatory writing basics

Volume 23, Issue 2 - Regulatory Writing Basics

Regulatory writing basics

The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meaning that they transmit the necessary information accurately, transparently, and clearly to the target audience (usually reviewers at the health agencies but readers might also be investigators or members of ethics committees).

In the Internet era, regulatory writers have instant and complete access to almost all the necessary guidelines governing these documents (and Raquel Billiones has gone to the trouble of compiling these guidelines; see p84). Yet there is actually rather little information in the public domain on how these guidelines should be applied and interpreted in practice. Some books are available on medical writing, but these have relatively little if anything to say about regulatory writing and focus on research articles and other aspects of medical communications. A quick search on the Amazon website revealed one book dedicated to regulatory writing.1 The book was published in 2008, but guidance changes and clarifications are issued in the form of Questions and Answers documents to address contradictory or ambiguous aspects of the guidance.2 So while the core skills needed for regulatory writing remain fairly constant, the details may change and the regulatory environment evolves.

This issue of Medical Writing, entitled Regulatory writing basics, is an attempt to fill, at least partially, the void of information on the subject and provide a useful reference guide for regulatory writers. (Here, I feel compelled to acknowledge that the original idea for this issue did not come from me but rather from Phil Leventhal, the regular Medical Writing editor). Regulatory writing is a wide field and so the scope of the articles has been limited to the types of document that an entry level regulatory writer is likely to encounter. It is also limited to pre-approval documents associated with drug development. The December 2014 issue of Medical Writing will be dedicated to the topic of post-approval.

At some point early in their careers, most entry-level regulatory writers work will work on a Clinical Study Report (CSR), which is covered in depth by Sam Hamilton (p86). For the most part, the guidelines covering the CSR are detailed and well developed, although they have occasionally been interpreted too literally. For example, the table of contents of the guidelines was interpreted by many companies as a template for their CSRs, resulting in the somewhat absurd situation of having the title page of the CSR listed as Section 1. This is a good example of the pitfalls of unthinking and rather slavish application of guidelines and also, I think, the desire of many companies to be as compliant as possible with the perceived letter of the guidelines while perhaps losing sight of their intent. A necessary skill of a regulatory writer is knowing when to treat guidance as set in stone and when it is appropriate to deviate from the letter of the guidance to ensure clarity and readability.

The Protocol is another document that writers may be involved in at some point in their careers. As Walther Seiler explains though (see p93), despite its obvious importance, the far-from

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  1. Wood LF, Foote MA, editor. Targeted regulatory writing techniques: clinical documents for drugs and biologics. Basel, Switzerland: Birkhäuser; 2009.
  2. See for example: ICH E3 guideline: structure and content of clinical study reports questions & answers (R1); 2012 Jul 6. 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


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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