HOME     CONTACT     BACK

 
 
 
THE PHARMA REVIEW (JULY - AUGUST 2010)

Regulatory Procedures in EU: A Review

Tarun Bharal, P.K. Nandi, S.K. Sahu

Introduction
The European pharma market contributes nearly one-fourth to the global pharma market share. As reported by IMS health the current global pharma market worth $825bn is expected to grow up to $975bn by 2013 constituting nearly $250bn through western European pharma market.1, 2 This lucrative European market therefore attracts different large/medium scale global pharma companies to launch their medicinal products in this region. The European Union (EU) is a highly regulated market in terms of the drug approvals. The companies striving for the EU thus undergo different stages of regulatory approval. In order to save the unnecessary regulatory burden, time and cost, the EU provides four different filing procedures. The different procedures offered by EMEA are National, Centralized, Mutual Recognition and Decentralized Procedures. The detailed descriptions for these procedures have been discussed in this article.

 

For full text of this article contact the publisher on info@kppub.com

 

Go to Content Index Page

PHARMA REVIEW - ARTICLES ARCHIVE ( COMPLETE LIST)

The above content is an abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate, New Delhi, India -110016
Tel.: 26855839, 20057149, Fax: 91-11-26855876
Email: info@kppub.com / fpc@vsnl.com, Website: http://www.kppub.com

 
 
 

 Copyright 2008. KONGPOSH PUBLICATIONS Pvt. Ltd.