NLGeneTherapy object
Specific requirements
Yes
Applicable legal framework
Gene therapy trials are covered by WMO (en)
Additional Information
According to section 13 (c) it is prohibited to conduct gene therapy trials which are intended to result in modifications to the subject’s germ line and genetic identity.
Related information on specific requirements regarding clinical trials on gene therapy and ATMP are provided on the CCMO website in section:
Home>Investigators>Types of research>Research on gene therapy/medicinal product with GMO