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

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

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) .

For more detailed technical specifications, you can access the full Guideline on Non-Clinical Studies for GTMPs via the official .