REGULATORY DOSSIER SUBMISSION AND REVIEW PROCESS IN EUROPE

Author : Dipa R Mehta Assistant Professor, Graduate School of Pharmacy, Gujarat Technological University, Ahmedabad

Page Nos : -

Abstract :

This article discuses the process of marketing authorization application and its regulated evaluation at agency’s end in the region of Europe. The cluster of 28 European Union (EU) member states, 3 European Economic Area (EEA) and European Free Trade Association (EFTA) states make European Union. As European nation consists of larger population, the government is alert regarding safety of the public health in EU. In the Europe, authorization of product is mandatory before they can be placed on the market in order to protect public health and ensure the availability of high quality, effective and safe medicines for European citizens. European drug authorization system offers different routes for such marketing authorization and same is discussed in this article.