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

Abstract

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.

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Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

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Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

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Nicole Bezuidenhout 

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Somsuvro Basu

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Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

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Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

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Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk