Chapter 17. Development and Regulation of Gene Therapy Drugs in Germany

Summary

In Germany gene therapy drugs are regulated in a similar way to other medicinal products under the German Drug Law although this does not officially define the term ‘gene therapy product’. Preclinical research is regulated under the German Gene Technology Law which covers the use of genetically modified organisms but not their application to humans. The manufacture and marketing of such products requires notification of the competent authority of the Land which reports to the Paul-Ehrlich Institute. Regulations to protect humans other than the patients and concerning environmental risk are provided by the German Law of Protection from Epidemics. Marketing authorisation comes from the European Medicines Evaluation Agency. Clinical studies using gene therapy can be initiated in Germany within a general time frame of less than six months. There is no public registry of gene therapy trials in Germany but an unofficial register is being constructed.