Regulatory Procedures in EU: A Review

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.

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