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125459 May 2026

: Checking if the patient might "shed" or spread the virus/vector through secretions.

: This guideline is a cornerstone for developers of Advanced Therapy Medicinal Products (ATMPs) in the European Union. 125459

: Characterizing potential immune responses to the viral vector or the new protein produced by the therapy. : Checking if the patient might "shed" or

: Evaluating whether the viral vector or therapeutic gene could unintentionally be passed on to future generations. 125459

: Defining scientific principles for non-clinical studies specifically for gene therapies, which differ significantly from conventional pharmaceuticals. Key Safety Requirements :