Volume 23, Issue 2 - Regulatory Writing Basics
The approval process of medicines in Europe
Author: Inga Abed
Abstract
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising each other's evaluations (the so called decentralised and mutual recognition procedures). It is a system that has evolved over the past half century from one with wholly separate national systems to one where EU countries now harness their regulatory and scientific expertise to harmonise and improve the evaluation of medicines across Europe. Today, the purely national procedure is rarely used by applicants and only when they seek marketing authorisation in a single Member State. Although the different procedures may give an impression of complexity, they have simplified the authorisation process across Member States, reducing the times for new medicines to obtain marketing authorisation and improving patient access to new medicines.
Download the full article
References
- Mathur VP, Sharma A, Dhillon JK, Kalra G. Moral philosophy of scholarly publications. Eur Sci Editing 2013;40(1):11–3.
- Roig M. When plagiarism is the most serious form of research misconduct. Eur Sci Editing 2013;40(1):27.
- Fascio Pecetto L. BioMed Central author academy. Eur Sci Editing 2013;40(1):17.
- BioMed Central author academy. London: BioMed Central; 2014 [cited 2014 Feb 3]. Available from: http://www.biomedcentral.com/authors/authoracademy
- Wheatley D. Drama in research papers. Eur Sci Editing 2013;40(1):14.
- Karon A. How to write a manuscript from a clinical study report. AMWA J 2013;28(4):160–1.
- From clinical study report to manuscript. Macclesfield, UK: EMWA; 2014 [cited 2014 Feb 4]. Available from: http://filemaker.emwa.org/workshops/view_workshop.php?recid=845
- Schrank K. Using editing checklists for more efficient editing. AMWA J 2013;28(4):164–6.
- Harting D. Working in the nonprofit sector: 10 job search tips for medical writers. AMWA J 2013;28(4):167–8.
- Kryder CL, Reidenbach F, Ero L, Krug S. Results of the 2013 needs assessment of medical communicators. AMWA J 2013;28(4):187–90.
Visit the EMWA website
Search
Articles
Member Login
Links
Editoral Board
Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Katharine Webb (INC Research, in Munich, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Karin Eichele (Novartis Pharma, Nürnberg, Germany)
- Greg Morley (Freelance, Madrid, Spain)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting, Norfolk, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Simon Page (Cambridge Medical Communication Ltd, Cambridge, UK)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Evguenia Alechine (Epsilon Scientific Communication, Buenos Aires, Argentina)
- Beatrix Doerr
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)