EMA: Draft Guidance on SmPC for ATMPs with Gene-modified Cells
The European Medicines Agency (EMA) has issued a 31-page draft guideline describing the information to be included in the Summary of Product Characteristics (SmPC), labelling and package leaflet for Advanced Therapy Medicinal Products (ATMPs) that contain genetically modified cells.
The document applies to cells genetically modified using methods (allogeneic or autologous) that include genome editing and viral vectors. It should support applicants and regulators with harmonized guidance on which information has to be included in the respective product information for those ATMPs.
Examples for chimeric antigen receptor T-cells (CAR-T) and clusters of differentiation 34+ (CD34+) modified cells are given in detail. These can be used as model wording for other types of genetically modified cells.
The draft was adopted by CHMP for release for consultation in July 2021 and will be open for comments until 31 October 2021.
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