Medical Writing Medical Writing in Paediatrics The MHRA perspective on the new pharmacovigilance legislation

Volume 21, Issue 2 - Medical Writing in Paediatrics

The MHRA perspective on the new pharmacovigilance legislation


Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the current European system in 1995. The background to the forthcoming changes dates back to 2003 when the European Commission decided to undertake an assessment of the pharmacovigilance system. Independent review and public consultation followed, as well as further work at the Commission, the European Medicines Agency (EMA) and EU member states, resulting in the publication of Regulation (EC) 1235/2010 and Directive 2010/84/EC on 31 December 2010.

The overriding purpose of the new package is to strengthen the public health system through better pharmacovigilance. All areas of post-marketing activities are subject to revision from ADR reporting, signal management, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post Authorization Safety Studies (PASS).

As well as the public health angle the new legislation also seeks to improve efficiency by having improved decision-making processes, reducing duplication and making better use of IT through the use of centralized systems and standards.

However, not all of the new measures will come into effect immediately and a period of transition will apply in a number of areas.

Marketing Authorization Holders (MAHs) and other stakeholders should refer to the EC Implementing Measures and the Good Vigilance Practice Modules produced by the EMA and member states.

This article hopes to highlight areas of interest to medical writers, identifying what the major changes are and when they come into play.

Download the full article



Medical writing in paediatrics: Children and the future
Message from the President
Challenges of paediatric drug development and impact of paediatric legislation
Writing applications for Paediatric Investigation Plans and waivers
Preparing the Paediatric Investigation Plan application
ADHD: A true neurodevelopmental disorder?
Medicines information for patients: Insights into research and practice for medical writers
The MHRA perspective on the new pharmacovigilance legislation
Are stem cells the future of healthcare?
O, safety, quo vadis?
Crowdpower in the era of ‘health 2.0’
Networking effectively: Essential for being successful in business
The moving image and your business
Forgive me for repeating myself: Self-plagiarism in the medical literature
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
English Grammar and Style
Out On Our Own


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