Medical Writing Regulatory Writing Basics The approval process of medicines in Europe
mew-150pxjpg

Volume 23, Issue 2 - Regulatory Writing Basics

The approval process of medicines in Europe

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

  1. Mathur VP, Sharma A, Dhillon JK, Kalra G. Moral philosophy of scholarly publications. Eur Sci Editing 2013;40(1):11–3.
  2. Roig M. When plagiarism is the most serious form of research misconduct. Eur Sci Editing 2013;40(1):27.
  3. Fascio Pecetto L. BioMed Central author academy. Eur Sci Editing 2013;40(1):17.
  4. BioMed Central author academy. London: BioMed Central; 2014 [cited 2014 Feb 3]. Available from: http://www.biomedcentral.com/authors/authoracademy
  5. Wheatley D. Drama in research papers. Eur Sci Editing 2013;40(1):14.
  6. Karon A. How to write a manuscript from a clinical study report. AMWA J 2013;28(4):160–1.
  7. 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
  8. Schrank K. Using editing checklists for more efficient editing. AMWA J 2013;28(4):164–6.
  9. Harting D. Working in the nonprofit sector: 10 job search tips for medical writers. AMWA J 2013;28(4):167–8.
  10. Kryder CL, Reidenbach F, Ero L, Krug S. Results of the 2013 needs assessment of medical communicators. AMWA J 2013;28(4):187–90.

Search

Articles

Regulatory writing basics
Message from the President
A guide to pre-approval regulatory documents
Effective authoring of clinical study reports: A companion guide
The clinical study protocol and medical writing: A good fit?
The Investigator's Brochure: A multidisciplinary document
An overview of the Common Technical Document (CTD) regulatory dossier
Good clinical practice (GCP): A universal call for ethics in biomedical research
Adverse event reporting: A brief overview of MedDRA
The approval process of medicines in Europe
Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One examining the fates of retracted articles
The needs assessment in continuing medical education
Origin and development of English for Medical Purposes. Part II: Research on spoken medical English
Did minor flaws in a new drug reveal major flaws in company publication practices?
What every medical writer needs to know
Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy
In the Bookstores
Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making
Regulatory Writing: The essence of regulatory writing as defined by its jargon
Medical Communication
News from the EMA
English Grammar and Style: Points of view
The Webscout
Gained in Translation: Science at the multilingual crossroads
Out On Our Own
The Light Stuff

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

  • Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: