Evolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR

By Sabine Ruehle, Pierre Omnes, Kathryn Parsley, Gabriel Bohl, Myra Widjojoatmodjo, Janneke Westra-de Vlieger, Jayne Hunt,
supportive members of the TOPRA Biotech and Clinical Trial SPIN groups2023-05-18T12:58:00

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The EU CTR replaced the EU CTD on 31 January 2022, which impacts investigational medicinal products that fall under genetically modified organisms (GMO-IMPs). This article discusses the specificities of the new CTR process for GMO-IMPs and updates on the GMO application processes in light of these changes.

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