This research deals with the drug approval process in Europe by focussing on the various marketing authorisation procedures, price controls and parallel trading. A snapshot of the biosimilars approval process is also provided along with the key strategic recommendations.
1 EXECUTIVE SUMMARY
Executive Summary of the Drug Approval Process in Europe
Overview of the European Drug Approval Process
2 RESEARCH METHODOLOGY
Research Methodology for Drug Approval Process in Europe
The Methodology
Scope and Objectives
3 REGULATORY CHALLENGES
Major Industry Challenges
Introduction
Regulatory Challenges in the European Union
4 OVERVIEW OF THE MARKETING AUTHORISATION IN EUROPEAN UNION
Marketing Authorisation Procedures
Marketing Authorisation Procedures in Europe
Comparing the Regulatory Systems in Europe and the United States
5 PRICE CONTROL AND PARALLEL TRADING
Overview of the Price Control and Parallel Trading in Europe
Analysis of Price Control and Parallel Trading
6 REGULATORY APPROVAL FOR BIOSIMILARS
Approval Process for Biosimilars
Biosimilars in Europe
7 STRATEGIC RECOMMENDATIONS
Key Findings
Recommendations for the European Drug Approval Process
8 APPENDIX
Decision Support Database
Number of Biotech Companies
Number of Biotetchnology Patents-European Patents Office
Number of Biotechnology Patents - USA Patents and Trade Mark Office
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