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

Date

February 19, 2025

Category

EU Regulations

Description

The European Medicines Agency (EMA) has adopted a new guideline for investigational advanced therapy medicinal products (ATMPs).

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. It becomes effective on 1 July 2025.

This new guideline can be found at https://www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical-trials-scientific-guideline