Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials

Table of contents

KeywordsInvestigational ATMPs, gene therapy medicinal product, cell therapy medicinal product, tissue engineered product, exploratory trial, first in human trial, confirmatory trial 
DescriptionThis 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.

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