JOIN4ATMP Partners’ Feedback Reflected in the European Commission’s Biotech Act Proposal
The European Commission has published the Proposal for the EU Biotech Act, together with a summary of the public consultation, marking an important milestone for the advanced therapies community.
JOIN4ATMP welcomes this development and is pleased to highlight that feedback provided by JOIN4ATMP partners Fondazione Telethon (Italy), VPH Institute (Belgium), and EURORDIS – Rare Disease Europe (France) during the consultation process has been taken up and reflected in the final proposal.
In particular, the proposal incorporates some of the simplifications advocated by JOIN4ATMP, most notably the recognition of the growing scientific and regulatory expertise in Advanced Therapy Medicinal Products (ATMPs) across Europe. As a result, the optional additional 50 days for the evaluation of clinical trial applications for ATMPs will be eliminated, leading to significantly shorter approval timelines and faster patient access to innovative therapies.
Another key element included in the proposal is the definition of “Centres of Excellence for Advanced Therapies”, an important concept that JOIN4ATMP partners strongly supported in their consultation feedback. These centres are expected to play a central role in strengthening expertise, streamlining development pathways and fostering collaboration across the ATMP ecosystem.
JOIN4ATMP encourages its community and stakeholders to explore the full European Commission consultation materials:
🔗 EC Biotech Act public consultation page (with summary report)
🔗 Consultation proposal (with feedback overview)
In particular, we invite you to consult the detailed Annex (see download below), which provides further insight into the measures and their expected impact, and the full feedback to the EU Biotech Act provided by JOIN4ATMP.
This outcome demonstrates the value of coordinated stakeholder engagement and underlines JOIN4ATMP’s commitment to shaping a more efficient, science-driven and patient-centred regulatory framework for advanced therapies in Europe.