Access Consortium's Advanced Therapy Medicinal Products Working Group

In 2023, the Access Consortium established a working group for advanced therapy medicinal products (ATMPs). ATMP is a term used in the legislative framework implemented by the European Union to regulate cell therapies, gene therapies and tissue engineered products.

The main goals of this group are to:

• foster interdisciplinary (quality, non-clinical, clinical) scientific discussions on emerging innovative therapeutic concepts and technologies
• establish an interdisciplinary forum for Access members to discuss ATMP-specific topics with a focus on assessing benefits and risks and on regulatory decision-making
• encourage mutual exchange and harmonization on the regulatory assessment of ATMPs
• explore potential synergies and opportunities for sharing work, fostering regulatory reliance and providing joint scientific advice
• publish guidance and recommendations on common areas where the group has established a harmonized approach, where appropriate