Regulatory Affairs and Marketing Approval



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.


European Union European Medicine Agency Marketing Authorization Adverse Event Reporting System Accelerate Approval 
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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.PharmaGuide LtdHertsUK

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