[Poster] The EU Reform of the pharmaceutical legislation: what changes can be expected for ATMP?

HAL: https://shs.hal.science/halshs-05619340v1 

Abstract

Background & Aims

After more than 5 years of preparatory works, the European Union (EU) is about to adopt a major reform of its pharmaceutical legislation in 2026. While Advanced Therapy Medicinal Products (ATMPs) will remain the only type of medicines specifically regulated by another legal instrument (Regulation 1394/2007 on ATMPs), the revision of general rules applicable to all medicines will impact on the legal framework for ATMPs.

Methodology

Research has been conducted on the content of the pharmaceutical legislation reform along the legislative process in order to identify the rules that will directly impact on ATMP regulation.

Results

Many measures such as a new legal definition for gene therapy medicinal products, the distinction of decentralised sites in the requirements for authorisation of manufacturing, the transfer of Environmental Risk Assessment at the European level for GMO-based medicines, data collection and planned clarification on hospital exemption, the recognition of technology platform and regulatory sandboxes aim to tackle current challenges in the ATMP regulatory pathway to market.

Moreover, general measures such as the modulation of regulatory data and market protection, the reduction of the timeline for the assessment of marketing authorisation applications by EMA favour timely and equitable access to safe, effective, and affordable medicines, including ATMPs. However, the restructuring of the EMA which aims to reduce the administrative burden is particularly questionable regarding the evolution for the Committee of Advanced Therapies (CAT) given its long-recognized role among stakeholders in the field.

Conclusion

The 2026 forthcoming reform of the EU pharmaceutical legislation will establish important changes for ATMP and their regulatory incentives through a clear commitment of the EU legislator to supporting innovation.

Poster

Authors

Aurélie Mahalatchimy, EuroGCT Deputy coordinator and WP4 leader; UMR 7318 DICE CERIC, Aix-Marseille University, Centre National de la Recherche Scientifique, Marseille, Provence-Alpes-Côte d’Azur, France

Valentin Roby, EuroGCT information officer on Ethical, Legal and Societal Issues

Christian Chabannon, Professor of Molecular Biology, MD, Centre de Thérapie Cellulaire. Institut Paoli-Calmettes Comprehensive Cancer Center & module Biothérapies du Centre d’Investigations Cliniques de Marseille, Inserm CBT-1409 –AMU –AP-HM -IPC

To be cited as:

A. MAHALATCHIMY, V. ROBY, C. CHABANNON, The EU Reform of the pharmaceutical legislation: what changes can be expected for ATMP?, ISCT 2026, 6-9 May 2026, Dublin, Ireland. (POSTER)