125459 [ 2026 Release ]

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

: Characterizing potential immune responses to the viral vector or the new protein produced by the therapy. 125459

: Evaluating whether the viral vector or therapeutic gene could unintentionally be passed on to future generations. : This guideline is a cornerstone for developers

Guideline on the Non-Clinical Studies Required before First ... - EMA 125459

The guideline, officially titled , provides a framework for non-clinical studies required before a gene therapy can be used in human clinical trials. Guide to EMA Guideline 125459