Drug Approval Process in Europe - An Outlook

Publication Date	December 2008
Publisher	Frost & Sullivan
Product Type	Report
Pages	51
ISBN Number	not applicable
Product Code	FRS01029

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Summary

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.

Content

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
  - Government R&D Investment in Biotechnology
  - Private Investment in Biotechnology