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EU Regulation is examined for danger of treating patients with new drugs

(Vienna, 12 Jan. 2011) A new EU Regulation could delay or endanger the rapid clinical use of the latest drugs on patients. An international consortium involving MedUni Vienna is now examining the possible effects.

So-called advanced therapy medicinal products (ATMPs) are used to treat patients with blood disorders and cancers and also serious traumatic or degenerative tissue and organ damage. These include in particular gene therapeutics, somatic cell therapeutics and biotechnologically processed tissue products which enable individual therapeutic measures.

On account of the proximity between research and clinical use, ATMPs are developed and produced very successfully at university institutions. A new EU Regulation (EC) No. 1394/2007 (revision period up to 2012) could endanger translational clinical research for such therapeutics, on the one hand with the industry-based guidelines for manufacture (“good manufacturing practice – GMP”) and on the other hand the low number of cases in many countries (in Austria 600 to 1000 affected patients per year). The new EU Regulation stipulates very expensive and time-consuming measures as well as facilities designed for industrial production. The sterile workplaces usually found in university research laboratories do not fulfil this Regulation, for example.

With this problem in mind, the European Commission-supported project “ACADEMIC GMP: The Impact of EU Regulation (EC) No. 1394/2007 on the development of Advanced Therapy Medicinal Products (ATMPs)” has been launched. Together with colleagues from England (University of Newcastle upon Tyne, Imperial College in London, University College in London), Sweden (University of Lund) and Germany (University of Regensburg, Johann Wolfgang Goethe University of Frankfurt, Hanover Medical School), at MedUni Vienna Ao. Univ. Prof. Dr. Nina Worel from the Department of Blood Group Serology and Transfusion Medicine and Ao. Univ. Prof. Dr. Hildegard Greinix from the Department of Medicine I (bone marrow transplantation) are examining the effects of the Regulation on patient care.

The goal of the researchers is, on the one hand, to create a platform for academic GMP facilities in Europe in order to guarantee “good manufacturing practice” with complex drugs in particular, and on the other hand to deliver an expert evaluation before the end of the revision period for the new Regulation and to help improve the laws for those affected.

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