The Regulatory Environment for Biopharmaceuticals in the EU 1669 Axel F Wenzel and Carina E A Sonnega

5.1 Introduction 1673

5.2 History and Background 1673

5.3 The Competent Regulatory Bodies 1676

5.4 What is the EU Authorities' Definition of a Biotechnological Product? 1681

5.5 The Regulatory Framework 1682

5.6 CP: The "Biotech" Procedure 1683

5.7 From Transcription to Prescription:

What is Different for Biotechnological Drugs? 1688

5.8 Biogenerics 1700

5.9 Conclusions and Outlook 1701

Was this article helpful?

0 0

Post a comment