The regulation of clinical gene therapy is covered primarily by the German Drug Law (Arzneimittelgesetz; AMG). According to German law, gene therapy is defined as a medical treatment with gene transfer medicinal products (section 4, paragraph 9 of the German Medicines Act). The Federal Office of Consumers Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) is the leading competent authority for deliberate release applications of GMOs. According to AMG the Paul-Ehrlich-Institut is the competent higher authority for gene transfer medicinal products.

Clinical gene therapy experiments are regulated by the Embryo Protection Law, the Gene Technology Law which regulates the pre-clinical field, the German Medicines Act, and the directive on the application of good clinical practice relating to the conduct of clinical trials on medicinal products for human use (GCP directive) and finally the relevant paragraphs in the German Criminal Code. Gene therapy trials needs an authorization by the Paul-Ehrlich-Institut, residing with the Ministry of Health (Bundesministerium für Gesundheit), and approval by the local ethics committee of the principal investigator. Every case has to be decided on an individual basis.

See also:
- 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.
- Gene therapy in Germany and in Europe: regulatory issues. Qual. Assur. J. 1997; 2: 141-152. This paper gives an overview on the regulatory issues of gene therapy in Europe focusing mainly on the specific situation in Germany. The view of the regulatory authorities is compared with the perspective of a pharmaceutical company. Additionally key features of the regulations in the UK and France are briefly outlined.