On February 6, 2025, we were thrilled to see several pioneering projects from the EIC ELMs Portfolio — PRISM-LT, -LoopOfFun-ELMs, NextSkins, Bio-HhOST, BioRobot-MiniHeart, ISOS Project EU, Bioaction EU, REMEDY — participate in the EIC-EMA Workshop on the Regulatory Framework of Engineered Living Materials (ELMs).

Co-organized by the European Innovation Council (EIC) and the European Medicines Agency (EMA), this workshop served as a vibrant exchange platform for ELM researchers to explore regulatory challenges. These innovative materials are set to transform medicine and biotechnology, marking a critical milestone for ELMs in Europe.

With keynotes from Barbara Gerratana (EIC), Orsolya Symmons (EIC), and Costantinos Ziogas (EMA), the event ignited insightful discussions. The panel, co-moderated by Falk Ehmann (EMA) and Laura Martinelli (PRISM-LT, INsociety), delved into essential topics like:

• ELM product classification and approval pathways
• Safety and compliance requirements
• Clinical trials for bioprinted and engineered tissues
• EMA’s guidance on ATMPs

This interactive session encouraged a plethora of questions and underscored the imperative for ongoing regulatory dialogue as ELM technologies continue to evolve. The workshop provided valuable insights into the changing regulatory landscape, highlighting the necessity for continuous collaboration among innovators, regulatory bodies, and industry stakeholders.