Europe – EMA Consults on Genetically Modified Cell Products Guideline

The European Medicines Agency (EMA) on Tuesday released a draft revision of its 2012 guideline covering quality, non-clinical and clinical aspects of medicines containing genetically modified cells for public consultation.

The draft revision was adopted for consultation by both EMA’s Committee for Advanced Therapies (CAT) and Committee for Medicinal Products for Human Use (CHMP) earlier this year and will be open for comments through July 2019.

EMA says the guideline is being updated to account for recent developments in the field of genetically modified cell therapies…