Clinical investigation of recombinant and human plasma-derived factor VIII products - Scientific guideline
This document covers clinical investigations to be conducted pre- and post-marketing authorisation for recombinant or human plasma-derived factor VIII products that are intended to use in the treatment and prevention of bleeding in patients with haemophilia A.
Keywords: Recombinant factor VIII, plasma-derived factor VIII, efficacy, safety, immunogenicity, inhibitor, potency assays
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Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2 (PDF/492.58 KB)
Adopted
First published: 13/08/2018
Last updated: 13/08/2018
Legal effective date: 01/02/2019
EMA/CHMP/BPWP/144533/2009 -
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Draft guideline on clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2 (PDF/378.86 KB)
Draft: consultation closed
First published: 30/10/2017
Last updated: 30/10/2017
Consultation dates: 30/10/2017 to 31/01/2018
EMA/CHMP/BPWP/144533/2009 Rev. 2 -
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Concept paper on revision of guidelines on the clinical investigation and core SmPC of recombinant and human plasma-derived factor VIII products (EMA/CHMP/BPWP/144533/2009 rev. 1) (EMA/CHMP/BPWP/1619/1999 rev. 2) (PDF/92.85 KB)
Draft: consultation closed
First published: 01/08/2016
Last updated: 01/08/2016
Consultation dates: 01/08/2016 to 30/09/2016
EMA/CHMP/BPWP/383118/2016
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Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 1 (PDF/332.13 KB)
Adopted
First published: 11/02/2016
Last updated: 11/02/2016
Legal effective date: 01/05/2016
EMA/CHMP/BPWP/144533/2009 rev. 1 -
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Draft guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 1 (PDF/330.21 KB)
Draft: consultation closed
First published: 01/06/2015
Last updated: 01/06/2015
Consultation dates: 01/06/2015 to 01/07/2015
EMA/CHMP/BPWP/144533/2009 Rev.1
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Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - First version (PDF/302.35 KB)
Adopted
First published: 01/08/2011
Last updated: 01/08/2011
Legal effective date: 01/02/2012
EMA/CHMP/BPWP/144533/2009 -
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Draft guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - First version (PDF/192.53 KB)
Draft: consultation closed
First published: 23/07/2009
Last updated: 23/07/2009
EMEA/CHMP/BPWP/144533/2009
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Draft guideline on the clinical Investigation of Recombinant Factor VIII and IX Products - Superseded (PDF/237.44 KB)
Draft: consultation closed
First published: 19/07/2007
Last updated: 19/07/2007
CPMP/BPWG/1561/99 rev.1 -
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Concept paper on the revision of notes for guidance on the clinical investigation of human plasma derived and recombinant factor VIII and IX products and the corresponding Core SPCs - Revision 1 - Superseded (PDF/34.15 KB)
First published: 15/12/2004
Last updated: 15/12/2004
EMEA/CHMP/BPWG/189106/2004 -
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Note for guidance on the clinical Investigation of Recombinant Factor VIII and IX Products - Superseded (PDF/111.4 KB)
Adopted
First published: 19/10/2000
Last updated: 19/10/2000
Legal effective date: 01/04/2001
CPMP/BPWG/1561/99