Eudralex Volume 3 Guideline on clinical investigation of recombinant and human plasma-derived factor IX products (replacing CPMP/BPWG/198/95 and CPMP/BPWG/1561/99)

Title:
Eudralex Volume 3 Guideline on clinical investigation of recombinant and human plasma-derived factor IX products (replacing CPMP/BPWG/198/95 and CPMP/BPWG/1561/99)

https://www.gmp-compliance.org/files/guidemgr/draft-guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-ix-products-revision-2_en.pdf

Origin/Publisher:

EMA - 7 Westferry Circus œ Canary Wharf œ London E14 4HB œ United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

Document Type:
Guideline
Content:
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 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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