EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

New Draft Guideline issued; consultation end date: July 2019

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorization. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.

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