EMA Issues Draft Guideline on Labeling for ATMPs With Gene-Modified Cells

The European Medicines Agency (EMA) has issued a draft guideline on information to be included in the Summary of Product Characteristics, labeling and drug leaflets for advanced therapy medicinal products (ATMPs) that contain genetically modified cells.

The draft guidance, which applies to cells genetically modified using methods that include genome editing and viral vectors, includes examples for chimeric antigen receptor T-cells (CAR-T) and clusters of differentiation 34+ (CD34+) modified cells.

The EMA is asking for comments on the draft guideline by Oct. 31.