The European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
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DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.
Published by European Commission (EC)
GMOGenetically Modified OrganismsThis Directive set the regulation of the environment of genetically modified organisms. The protection of human health and the environment from the deliberate releaset 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 TrialsGuideline 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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