PRISM-LT participates in EIC-EMA Workshop on the regulatory framework of engineered living materials

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On February 6, 2025, PRISM-LT took part in the EIC-EMA Workshop on the Regulatory Framework of Engineered Living Materials (ELMs)—a key event marking the first interaction between the European Medicines Agency (EMA) and representatives of this emerging field with health applications. The workshop provided an informal collaborative platform for discussing regulatory challenges and frameworks for novel medical technologies, with participation from multiple EIC ELMs Portfolio projects. 

Organized by the European Innovation Council (EIC), the workshop brought together policymakers, researchers, and industry representatives to discuss the regulatory challenges facing ELMs—biologically active materials with transformative potential in several fields, including medicine and biotechnology. Representatives from several EIC-funded initiatives, including PRISM-LT, had the chance to outline their work and regulatory concerns, setting the stage for an in-depth exploration of the sector’s evolving needs. 

The workshop began with opening remarks from Barbara Gerratana (EIC Programme Coordination Manager), Orsolya Symmons (EIC Project Manager for Health and Biotechnology) and Constantinos Ziogas (Head of the EMA SMEs Office), setting the stage for a focused discussion on regulatory considerations for ELMs. The following panel discussion, co-moderated by Falk Ehmann (Head of Innovation and Development Accelerator at EMA) and PRISM-LT coordinator Laura Martinelli (CEO of INsociety) tackled the finer details of regulation and featured insights from several EMA experts. Among the key challenges were:

  • The classification of ELM-based products and its impact on approval pathways 
  • Safety and compliance requirements 
  • The role of clinical trials in evaluating bioprinted and engineered tissues 
  • Existing regulatory frameworks, including EMA’s guidance on Advanced Therapy Medicinal Products (ATMPs). 

The workshop provided an interactive platform for discussing regulatory uncertainties, with participants raising specific questions on classification, approval pathways, and compliance challenges unique to ELMs. The discussion highlighted the need for further regulatory engagement as these technologies continue to evolve. 

PRISM-LT welcomes the opportunity to engage in these pioneering regulatory discussions and contribute to shaping the future framework for engineered living materials. The workshop provided valuable insights into the regulatory landscape for novel medical technologies and underscored the importance of ongoing dialogue between innovators, regulatory bodies, and industry stakeholders.