EMA Adopts Collaborative Approach With ATMP Guideline Update

By Pam Dhadda, Associate Director, CMC Cell and Gene Therapy at PharmaLex

The European Medicines Agency (EMA) has taken a significant step forward in the regulation of advanced therapy medicinal products (ATMPs) by releasing an updated draft guideline on the quality, non-clinical, and clinical requirements for these innovative therapies in clinical trials. ATMPs, which include cell and gene therapies, represent a rapidly advancing sector with the potential to deliver transformative treatments for a wide range of diseases. The updated guideline, which follows a comprehensive review process and extensive stakeholder consultation, underscores the EMA's commitment to a collaborative approach.

This approach aims to address the unique challenges posed by the diverse technologies within the ATMP landscape while striving for harmonization and clarity in regulatory expectations. Although the guideline introduces valuable updates and clarifications, it also highlights ongoing issues that could impact industry innovation and the development of ATMPs in Europe. This article delves into the key changes in the guideline, the feedback from stakeholders, and the implications for ATMP developers.