Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products

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Download document Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products
Reference number EMA/CHMP/BPWP/144533/2009 Rev. 2
Status draft: consultation open
First published 2017-10-30
Last updated 2017-10-30
Consultation start date 2017-10-30
Consultation end date 2018-01-31
Email address for submissions BPWPsecretariat@ema.europa.eu

Summary

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance covers clinical investigations to be conducted pre- and post-marketing authorisation. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.