Clinical investigation of recombinant and human plasma-derived factor IX products
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Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2 (PDF/574.17 KB)
Draft: consultation open
First published: 30/11/2018
Last updated: 19/12/2018
Consultation dates: 03/12/2018 to 30/06/2019
EMA/CHMP/BPWP/144552/2009 rev. 2 Corr.1 -
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Questions and answers on the revision of the guidelines on clinical investigation of recombinant and human plasma-derived factor VIII products (EMA/CHMP/BPWP/144533/2009 Rev. 2) and FIX products (EMA/CHMP/BPWP/144552/2009 Rev. 2) (PDF/136.85 KB)
First published: 30/11/2018
| Keywords | Recombinant factor IX, plasma-derived factor IX, efficacy, safety, immunogenicity, inhibitor, thrombogenicity, anaphylactic reactions, potency assays |
| Description | This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use in the treatment and prevention of bleeding in patients with haemophilia B. The guideline 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. |
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Revision 1 Under revision |
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In operation: 01/09/2015–present
Published: 01/06/2015
Published: 06/01/2015 |
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First version
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In operation: 01/02/2012–01/09/2015
Published: 23/07/2009 |
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Superseded document
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Published: 19/07/2007
Published: 15/12/2004
In operation: 01/04/2001–01/02/2012 |
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Superseded document
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Published: 19/07/2007
Published: 15/12/2004
In operation: 01/04/2001–01/02/2012 |
