EMEA publishes Draft Guidance on Plasma and Urine Derived Medicinal Products and CJD
The proposed document will replace the CHMP Position statement on Creutzfeld-Jakob Disease and plasma-derived and Urine Derived Medical Products (EMEA/CPMP/BWP/2879/02 Rev 1)
These guidelines need to be updated because there have been 4 cases of vCJD infection associated with blood transfusion of non-leucodepleted red blood cells. TSE infectivity has also been detected in urine in some animal models.
In order to help the CHMP with developing this position statement they are seeking input from Industry and the Public.
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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