Labelling, Packaging and Traceability in ATMPs Explained: Global Compliance Framework for 2025 Regulatory Guide to Labelling, Packaging and Traceability in ATMPs: Ensuring Safety and Compliance Introduction to Labelling, Packaging, and Traceability in ATMPs Advanced Therapy Medicinal Products (ATMPs) — including gene therapies, somatic-cell therapies, and tissue-engineered products — present unique regulatory challenges due to their complexity, patient specificity, and logistical requirements. Unlike conventional medicines, ATMPs may be prepared on a per-patient basis, requiring robust systems for labelling, packaging, and traceability. Global regulators such as the FDA, the EMA, and the CDSCO mandate strict requirements to ensure product integrity, patient safety,…