High-level analysis of European Union law on Advanced Therapy Medicinal Products

This study has been written for an academic online encyclopaedia published by Oxford University Press: The Oxford Encyclopedia of EU Law (OEEUL).

It provides complete and detailed information on European Union law on Advanced Therapy Medicinal Products (ATMPs). Starting with the legal definitions and examples illustrating what ATMPs are, this article explains the importance and complexity of classifying these innovative medicines—an essential step in determining the regulatory pathway that will apply to them and which will enable patients to access these treatments. It also shows how the EU legislation regulates ATMPs along the entire therapeutic chain, including starting materials, clinical trials, manufacturing, marketing authorization, pharmacovigilance and follow-up requirements, traceability, assessment for national decisions on pricing and reimbursement, and patentability of ATMPs. Then, it discusses ethical aspects of ATMPs, and finally the perspectives on the evolution of EU legislation regarding ATMPs.

This study covered the European Union from the point of view of the law as an academic discipline. It focuses on Advanced Therapy Medicinal Products as defined in EU law, i.e. including Gene Therapy Medicinal Products, somatic Cell Therapy Medicinal Products, Tissue Engineered Products and Combined Advanced Therapy Medicinal Products (integrated combination with a medical device).

This study provides complete and detailed information on European Union law on Advanced Therapy Medicinal Products (ATMPs). 

• It provides the legal definitions of Advanced Therapy Medicinal Products as defined in EU law, i.e. including Gene Therapy Medicinal Products, somatic Cell Therapy Medicinal Products, Tissue Engineered Products and Combined Advanced Therapy Medicinal Products (integrated combination with a medical device), with concrete examples illustrating what ATMPs are.
• It explains the importance and complexity of classifying these innovative medicines—an essential step in determining the regulatory pathway that will apply to them and which will enable patients to access these treatments. 
• It shows how the EU legislation regulates ATMPs along the entire therapeutic chain, including starting materials, clinical trials, manufacturing, marketing authorization, pharmacovigilance and follow-up requirements, traceability, assessment for national decisions on pricing and reimbursement, and patentability of ATMPs. 
• It discusses ethical aspects of ATMPs on the basis that even though the EU does not have a Treaty conferred power to regulate ethics, many ethical considerations have been integrated into EU law, especially in the field of ATMPs.

It finally analyses what are the perspectives on the evolution of EU legislation regarding ATMPs in the context of the EU reform of pharmaceutical legislation that should be adopted by the end of 2026.

• Introduction
• Definitions
• The Importance of Legal Qualification of Medicines as ATMPs
  • Industrially produced vs non industrially produced ATMPs
  • ATMPs vs non-ATMPs
  • Scientific recommendation on ATMPs classification
• Lifecycle of ATMPs
  • ATMPs’ starting materials
  • Clinical trials of ATMPs
  • Manufacturing of ATMPs
  • Marketing authorization of ATMPs
  • Pharmacovigilance and follow-up requirements
  • Traceability
  • Assessment of ATMPs for national decisions on pricing and reimbursement
  • Patentability of ATMPs
• Ethical Aspects of ATMPs
• Perspectives on ATMPs Legislation Evolution

I. FAUSCH, A. MAHALATCHIMY, “Advanced Therapy Medicinal Products”, in S. GARBEN, L. GORMLEY, The Oxford Encyclopedia of EU Law [OEEUL], February 2025.