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Regulatory Affairs and Marketing Approval

Chapter

Abstract

This chapter gives some background to the main regulatory agencies and then provides details of the applications required to gain permission to market a drug. The post-marketing surveillance phases are also covered, and the chapter concludes with a brief overview of marketing to physicians.

Keywords

European Union European Medicine Agency Marketing Authorization Adverse Event Reporting System Accelerate Approval 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.PharmaGuide LtdHertsUK

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