PETER FELDSCHREIBER
4 New Square Lincolns’ Inn, London WC2 3AJ, United Kingdom

Abstract

This article describes the legal and administrative frameworks and procedures for the regulation, grant of marketing authorization and subsequent safety vigilance activities required to comply with European law within member states of the European community.
In particular we consider the components of the submission dossier for authorization, the methodologies used to evaluate the appropriate risk: benefit of new medicinal products and the different procedures used in submission to ensure harmonization of product authorizations and details throughout the EU.

INTRODUCTION
The European system for regulating the manufacture and distribution of medicinal products developed in the years following the thalidomide disaster in the early 1960s. Over the past few years there have been dramatic changes in the way the pharmaceutical industry discovers and develops new products. For instance the production of recombinant macromolecules and monoclonal antibodies, the development of the new oligonucleotide biochemistry and other molecular biological approaches to therapeutics are transforming the industry. These scientific advances have to be closely matched by new regulatory methodologies to evaluate the safety and efficacy of a new medicinal product such that an appropriate benefit risk profile for a particular patient group with particular disease characteristics may be safely placed on the market (1). Over the past 60 years a complex regulatory framework has and continues to evolve to ensure the objective evaluation of new medicines and the monitoring of the safety of existing medicines.

EUROPEAN REGULATORY LEGISLATION AND ITS ADMINISTRATION
The legislation to appropriately update the m ...