: Defining scientific principles for non-clinical studies specifically for gene therapies, which differ significantly from conventional pharmaceuticals. Key Safety Requirements :
: This guideline is a cornerstone for developers of Advanced Therapy Medicinal Products (ATMPs) in the European Union. 125459
The number most commonly refers to a specific scientific guideline established by the European Medicines Agency (EMA) regarding the development of Gene Therapy Medicinal Products (GTMPs) . 125459