Guideline on Clinical trials with medicinal products that contain or consist of GMOs must also comply with applicable requirements under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
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European Commission. Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified. Version 5. November 2021
Published by European Commission (EC)
GMOGood PracticeClinical Trials