Regulation No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Online Version

Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine [Convention of Ovideo]. Online Version

Further background information is provided here, for example:

Albrecht, S. / König, H. / Sauter, A. (2021): Genome Editing am Menschen. Endbericht zum Monitoring. TAB-Arbeitsbericht Nr. 191. Berlin: Büro für Technikfolgen-Abschätzung beim Deutschen Bundestag (TAB): 171ff. Online Version(German)

Yotova, R. (2017): The regulation of genome editing and human reproduction under international Law, EU law and comparative law. Report commissioned by the Nuffield Council on Bioethics  in order to inform the Council’s working group on genome editing and human reproduction. Online Version

Nordberg, A. / Minssen, T. / Feeney, O. / de Miguel Beriain, I. / Galvagni, L. / Wartiovaara, K. (2020): Regulating germline editing in assisted reproductive technology. An EU cross-disciplinary perspective. In: Bioethics 34, 16–32. Online Version