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


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