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Gene Therapy Legislation in Germany

The regulation of clinical gene therapy is covered primarily by the German Drug Law (Arzneimittelgesetz; AMG). According to German law, gene therapy is a medical treatment with gene transfer medicinal products excluding vaccines against infectious disease (section 4, paragraph 9 of the Drug Law). Marketing authorisation occurs via the European centralised procedure at the European Medicines Agency (EMA). Alternatively, Advanced Therapy Medicinal Products (ATMPs) including gene therapy products can be excepted from the obligation of obtaining marketing authorisation via the centralised procedure under certain conditions (Regulation (EC) No 1394/2007 amending Directive 2001/83/EC; so called “Hospital Exemption Regulation”).

Gene therapy trials require authorization by the Paul-Ehrlich-Institut (www.pei.de), residing with the Ministry of Health (Bundesministerium für Gesundheit), and approval by the local ethics committee of the principal investigator. Guidance on the submission of clinical trial applications is provided by the 3rd Notification on the Clinical Trial of Medicinal Products for human Use. Germany generally considers clinical trials with medicinal products containing genetically modified organisms (GMOs) as deliberate release and requires an environmental risk assessment (ERA) performed in accordance with Annex II and based on information as per Annex III to the Directive 2001/18/EC. The deliberate release of a GMO within a clinical trial is authorised by the Paul-Ehrlich-Institut in consultation with the German GMO competent authority, the Federal Office of Consumer Protection and Food Safety (BVL). Any handling of the GMO-containing medicinal product outside the clinical trial falls within contained use which is regulated by the Genetic Engineering Act (GenTG).

Many details on the requirements for gene therapy clinical trials with respect to quality, non-clinical and clinical data of the product have been published in a special issue of the Bundesgesundheitsblatt (Volume 53, 2010).

See also:
- Regulatory requirements for clinical trial and marketing authorisation application for gene therapy medicinal products. 2010. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 53, 30-37.
- Environmental risk assessment for medicinal products containing genetically modified organisms. 2010. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 53, 52-57.
- Gene Therapy in Germany, an Interdisciplinary Survey. Supplement of the German Gene Technology Report. November 2008. This report attempts to give a comprehensive account of the current state of research and of the potential of gene therapy in Germany as well as an interdisciplinary analysis, taking into account scientific and medical facts, the legal framework, ethical implications and the perception and assessment by the public.

(Last reviewed by the Competent Authority: 8 June 2011)