NLGeneTherapy object

Specific requirements

Yes

Applicable legal framework

For clinical gene therapy, the Arzneimittelgesetz (AMG, Medicinal Products Act) and GCP-Verordnung (GCP-V, GCP ordinance) have to be considered. (see also: unofficial translations published in the Bundesgesetzblatt (Federal Law Gazette)): Medicinal Products Act (AMG), English version.

Gene transfer products are medicinal products according to section 2 subsection 1 AMG. Section 4 subsection 9 AMG contains a detailed definition.
The legal procedure is generally the same as for medicinal products for human use, specific requirements are indicated in the related sections.

Additional Information

The German Gentechnikgesetz (Gene Technology Act) does NOT cover the issues of clinical gene therapy.
The GenTG only has to be applied for preclinical research including the construction, use and storage. In these cases an approval according to section 8 of the GenTG is necessary. The competent authority concerning this approval is the Landesbehörde (see ZLG-German register of the competent authorities responsible pursuant to Landesrecht)

As a matter of principle Good Manufacturing Practice (GMP) is required for the manufacture of medicinal products for human use.
The (1) German Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV) and the (2) EC-GMP-Guideline cover this issue.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395