Medical Writing Post-Approval Regulatory Writing Post-approval regulatory writing

Volume 23, Issue 4 - Post-Approval Regulatory Writing

Post-approval regulatory writing



Very often in clinical development, we are focused solely on gaining marketing authorisation for our drugs – the scramble to be first to market, or to bring the next ‘blockbuster’ to patients. Phase I to Phase III is our primary goal. And to a large extent, this is how it should be – there's no point in spending millions on research and development if the drug is never given to patients.

However, what happens afterwards? As medical writers, does our job finish once we've written up the clinical study reports and dossiers, answered the regulatory authorities' questions, and helped a company gain approval? I'd like to think not – I'd argue that medical writers are needed just as much to keep a drug on the market as they are to get it there in the first place.

I'm not immune to the pull of a sexy CTD of course, and I find it almost impossible to refuse when a client calls for help with ‘a new type of…’ or ‘the only treatment for…’. But is the rush to the altar of marketing approval where we should be putting ALL of our focus and energy? Isn't that like putting all of our effort into the birthing of a marketing authorisation and none into keeping the resulting infant drug alive?

Post-approval documentation has always ‘been there’ of course, but was perhaps seen as a necessary evil – a drain on resources with no return on investment. However, in the last few years it has undergone something of a renaissance; driven by the 2012 change in PV legislation and, I believe, the increasing thirst and demand for high quality information from patients, lobbyists, and support groups. The pharmaceutical industry has embraced these changes and is rising admirably to the challenge, but not without teething problems, and this is where the skills of a medical writer can really come to the fore.

This issue of Medical Writing is dedicated to post-authorisation documents and the medical writer's role in them. The first of our feature articles is from Dakshayini Kulkarni and discusses the pharmacovigilance system master file (PSMF). Her article gives a practical guide to handling and improving this constantly evolving document, based on findings from PSMF inspectors.

Sunil Modali explains the differences between and potential difficulties in writing pre- and post-authorisation documents; something that writers more used to pre-authorisation documents may not have considered. Sarah Richardson outlines the role of the strategic medical writer in post-authorisation documents and gives an outline of the legislation. The intricacies of writing non-interventional post-authorisation safety studies are described beautifully by Greg Morely, and finally, Amy Whereat looks at advisory boards specifically, and the issues and potential pitfalls in writing reports for them.

I thank all of the contributors for their willingness to share their knowledge and experience in this area, and for the hard work they have put into their articles. My thanks also to Phillip Leventhal for bravely dedicating a whole issue to this topic and for trusting me with his ‘baby’. Finally – thanks to all of you, for reading this issue. Please do send me your feedback, and let me know if these articles have helped any of your ‘infant drugs’ survive!



Download the full article



Post-approval regulatory writing
President's Message
Responding to concerns over the PSMF: Inspectors offer key insights
Post-approval regulatory writing – How different is it from writing pre-approval documents?
Strategic medical writing in the post-authorisation phase
Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report
Writing publications for advisory boards
The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance
Profile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting
English Grammar and Style
News from the EMA
The Webscout
In the Bookstores
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