The regulation of clinical gene therapy is covered primarily by the German Drug Law (Arzneimittelgesetz; AMG). 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 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.

See also: 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.

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