[Poster] The European Commission proposal for a new regulation on biotechnology: why does it matter for ATMP?

HAL: https://shs.hal.science/halshs-05619334 

Abstract

Background & Aims

As part of the European Commission (EC) life sciences strategy, a proposal for a new European regulation aims at establishing a framework to strengthen the biotechnology and biomanufacturing sectors and has been published on 16-DEC-2025. The proposal targets “health biotechnology” with a wide definition, including biotechnological applications relevant to animal and plant health, veterinary public health, and food safety, all contributing to the protection of human health. Does it matter for ATMP?

Methodology

Research has been conducted on the content of the new EC proposal on a so-called “EU Biotech Regulation” to identify rules that could directly impact on ATMP regulation, development, evaluation and commercialization.

Results

We identified several rules that will impact on the regulation of ATMP.

A first set of rules includes proposed direct amendments to the ATMP Regulation : the possibility to modify the legal definition of Tissue Engineered Products in light of technical and scientific advances, the exemption from the requirement to submit an Environmental Risk Assessment for Clinical Trials (CT) of investigational ATMP (IATMP) based on Genetically Modified Organisms where there is no or negligible risks to human health and the environment.

A second set of rules includes proposed amendments to the CT Regulation, which explicitly mention ATMP: the exemption from CT requirements regarding manufacturing and import for IATMP where there is no or negligible risks to human health and the environment, the simplification and shortened timeline for authorisation of CT in the EU with the removal of the additional 50 days of assessment currently applicable to ATMP, a simplified procedure for the IATMP dossier with the possibility to refer to an active substance or a certified platform technology master file in a CT application.

A third set includes newly created rules : a regulatory status repository including the recommendations for ATMP classification issued by the Committee for Advanced Therapies (CAT), the EC recognition of centres of excellence for ATMP and of biotechnology testing environments or advanced biotechnologies, enabling access to supportive measures.

Conclusion

Changes proposed by the EU Biotech Regulation are worth to be evaluated by the gene and cell therapy community. The legislative process towards the adoption of the final text deserves to be followed.

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 European Commission proposal for a new regulation on biotechnology: why does it matter for ATMP?, ISCT 2026, 6-9 May 2026, Dublin, Ireland. (POSTER)