The approval process of medicines in Europe

Inga Abed

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.

Keywords: European Medicines Agency, Centralised procedure, Decentralised procedure, Mutual recognition procedure, Medicines approval

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.

Volume 23, Issue 2 - Regulatory Writing Basics

The approval process of medicines in Europe

Author: Inga Abed

Abstract

References

Search

Articles

Links

Editoral Board