Medical Writing Good Pharma Good regulatory practice and the role(s) of a regulatory affairs professional

Volume 22, Issue 4 - Good Pharma

Good regulatory practice and the role(s) of a regulatory affairs professional


Good Regulatory Practice is a regulatory affairs quality standard that is based on trained people who understand their professional role and work in an environment that follows standards and processes. This article illustrates the diversity of roles represented by a regulatory affairs professional and explains the importance of focused training of personnel, and of generating departmental regulatory intelligence. Good Regulatory Practice is a prerequisite for achieving an optimal balance between regulatory requirements, anticipated target profile, and time to market.

Download the full article


  1. Hägglöf I, Holmgren A. Roles and responsibilities of regulatory authority and company. In: Hill RG, Rang HP, editors. Drug discovery and development. 1st ed. London: Churchill Livingston; 2006. 281–97.
  2. European Industrial Pharmacist Group. Guide to Good Regulatory Practice 2008. Available from:
  3. Alexio F. European Focus Portugal – guide to good regulatory practice. Regulatory Rapporteur 2005(May):31–34.
  4. Lassoff P. The hub of the wheel. Pharmaceutical Executive 2007 Feb–Mar. Available from:
  5. Brown-Tuttle M. Transforming information into intelligence. Regulatory Focus 2010;15(8):28–34.
  6. Garfield E. The impact factor and using it correctly. Unfallchirurg 1998;48(2):413.
  7. American Society for Cell Biology. San Francisco Declaration on Research Assessment. 2013 [cited 2013 Sept 21] Available from:



Good pharma
Message from the President
Transparency and the healthcare industry: The Sun is shining
Sunshine spreading across the Atlantic and over Europe
Bad karma
If a misinformed voice speaks out in the wilderness and no one refutes it, does it make a sound? A call to advocacy
The Big Pharma conspiracy theory
Editorial: Pharmaism
Legal remedies for medical ghostwriting: Imposing fraud liability on guest authors of ghostwritten articles
A decade of change: A new ISMPP has arrived
Selling evidence over the counter: Do community pharmacists engage with evidence-based medicine?
Good regulatory practice and the role(s) of a regulatory affairs professional
Profile: An interview with Dr Gustavo A. Silva on the concept of public health in medical writing and translation
AuthorAID: An international service and chance to serve
India as a hub for ethical and evidence-based medical communications
Providing value for medicines in older people
In the Bookstores
Journal Watch
The Webscout
Regulatory Writing
Medical Communications
Manuscript Writing
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

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