In January, the Paul-Ehrlich-Institut, the German Federal Institute for Vaccines and Biomedicines published a document addressing all marketing authorisation holders of cellular blood products and therapeutic single plasma as well as holders of an authorisation for stem cells for haematopoetic reconstitution.
In a written hearing pharmaceutical companies could provide input to the Paul-Ehrlich-Institut (PEI). Following the PEI issued the notification on "Prevention of adverse effects of medicinal products Imposition of conditions on the marketing authorisations for cellular blood components and fresh frozen plasma" in the letters of 20 January 2010 and 21 December 2011. The subject is Imposition of conditions pursuant to Section 28 (3) c AMG (Arzneimittelgesetz, German Medicines Act) for the purpose of risk prevention to assure the safety of blood components for transfusion and of stem cell products for haematopoetic reconstitution: Testing for HIV, HBV and HCV.
The measures ordered are based on Section 28 (3) c of the German Medicines Act (Arzneimittelgesetz, AMG). According to the AMG, the Paul-Ehrlich-Institut can decide among other things that in the control of the starting material of biological medicinal products, specific requirements need to be fulfilled if this is necessary for safeguarding the appropriate quality or for risk prevention.
The measure serves to ascertain that during the manufacture of blood components and stem cell products, the test methods for the detection of HIV, HBV, and HCV comply with the state of science and technology.
The Paul-Ehrlich-Institut considers this measure for the purpose of risk prevention as necessary, since it assures that the test methods used for donor screening fulfil the particular requirements for screening tests used in the manufacture of blood and stem cell preparations.