Regulatory Factsheet
Clinical Trials with Genetically Modified Organisms (EU)
Investigational medicinal products (IMPs) that contain or consist of genetically modified organisms (GMOs) constitute a special regulatory case. In addition to the standard review of the clinical trial application by the competent authority and ethics committee, GMO IMPs are subject to an assessment and approval process under the GMO legislation. For more information, download our 3-page factsheet on Clinical Trials with Genetically Modified Organisms (EU).
