CHMP position statement on Creutzfeldt-Jakob disease and plasma ...

The outcome of the estimates of the theoretical potential of manufacturing processes to reduce
infectivity and the results of product-specific investigational studies should be reported to the relevant
competent authorities for the medicinal products concerned, as information becomes available.
Applicants submitting new marketing authorisation applications for plasma-derived medicinal products
will be expected to include such information in the application dossier. The outcome of the estimation
of the theoretical potential to reduce infectivity should always be included in the application.
In support of these recommendations, <strong>CHMP</strong>’s Biotechnology Working Party, with the involvement of
external experts, has developed guidance on how to investigate manufacturing processes with regard
to vCJD risk. 5a
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