Points to consider for assessors - New factor VIII and factor IX products: potency determination for labelling and assays for testing post-infusion samples

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BPWP/231587/2015
Published07/12/2015
Effective from07/12/2015
Keywordshaemophilia A, haemophilia B, factor VIII and factor IX products
Description

This document has three objectives:
 

  • The description of the product potency characteristics which should be provided by the manufacturer in support of the chosen method for final product potency labelling,
  • The identification of key points which should be addressed to ensure a robust system for potency determination in the final product and in patient plasma post-infusion,
  • To advise assessors (quality, clinical and RMP) to liaise for multidisciplinary evaluation of potency determination for labelling and testing of post-infusion samples.

These points apply to all new factor VIII and factor IX products, i.e. products not previously registered in the EU including plasma-derived, recombinant and modified products. The principles may also apply in other scenarios related to potency determination. This document should be read in conjunction with the referenced documents which provide further information.


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