The European Medicines Agency has released a draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells for public consultation.
This guideline aims at defining scientific principles and shall provide guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. The guideline focuses on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.
Please send your feedback by 31 July 2019. You can access the draft guideline by clicking here.