Medical Writing Public Disclosure Preparing anonymisation reports in general and for an orphan drug in particular

Volume 27, Issue 2 - Public Disclosure

Preparing anonymisation reports in general and for an orphan drug in particular


In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and therebymade publicly available. Before the clinicalreports can be published, the applicant isrequired by legislation to protect personaldata to ensure individual clinical studyparticipants and other individuals involved inthe study are not identified. The applicant hasto describe how data protection of personaldata has been ensured in an anonymisationreport (AnR). This article describes the diff -er ent steps necessary to prepare an AnR ingeneral, a company’s first experience ofpreparing an AnR for an orphan drug, and thekey points learned from this experience.

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  1. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. Available from: Available from:
  2. European Medicines Agency website on Clinical data. Available from: Available from:
  3. Billiones R. Anonymisation reports from 2016 to 2017: A preliminary analysis. Med Writ. 2018;27(4):22–6.
  4. Henriksen-Bulmer J, Sheridan J. Re-identification attacks – A systematic literature review. IJIM. 2016;36:1184–92.
  5. EMA Questions & Answers on the External Guidance of Policy 0070 on Clinical Data Publication (CDP). Available from: Available from:



President’s Message
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
Upcoming issues ofMedical Writing

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Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Claire Chang

Barbara Grossman

Amy Whereat

Petal Smart

John Plant

Sampoorna Rappaz

Sarah Milner

Section Editors

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

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk