Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guideline
Table of contents
This guideline provides guidance on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products.
Keywords: Investigational ATMPs, gene therapy medicinal product, cell therapy medicinal product, tissue engineered product, exploratory trial, first in human trial, confirmatory trial