EMEA publishes a concept paper on the need for a position statement on CJD and Plasma-Derived and Urine-Derived Medical Products.
The last revision of the “CHMP position statement on CJD and plasma-derived and urine-derived medicinal products” (EMEA/CHMP/BWP/2879/02/rev.1) was published in June 2004.
The document is the current EMEA/CHMP guidance on CJD and vCJD and plasma-derived and urine-derived medicinal products. It includes recommendations for these products based on the knowledge on CJD and vCJD epidemiology, human tissue distribution of infectivity/abnormal prion protein and infectivity in blood.
The current position statement dates from 2004. Additional information has been accrued in this field since 2004 including the finding of four cases of vCJD infection associated with blood transfusion of non-leucodepleted red blood cells.1,2 TSE infectivity has also been detected in urine in some animal models3,4,5,6 in the clinical phase of the disease.
The CHMP opinion and recommendations reflected in the position statement were based on the knowledge on CJD and vCJD at the time of publishing. The progress in the field during the subsequent years reinforces the need to update the content of the document and to review the recommendations for these products.
The current position statement covers plasma-derived medicinal products and urine-derived medicinal products. Currently, there is no specific guidance on CJD and vCJD and advanced therapy medicinal products based on human tissues.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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