Risk-Based Approach for ATMP Evaluation Explained: Regulatory Frameworks and Best Practices Implementing a Risk-Based Approach for ATMP Evaluation: Global Regulatory Insights Introduction to the Risk-Based Approach for ATMPs Advanced Therapy Medicinal Products (ATMPs) — including gene therapies, somatic-cell therapies, and tissue-engineered products — present both groundbreaking potential and unique risks. Unlike conventional pharmaceuticals, ATMPs may involve genetic modification, patient-specific processes, or complex tissue integration. Regulatory agencies such as the FDA, the EMA, and the CDSCO increasingly emphasize a risk-based approach to ATMP evaluation. This method tailors requirements based on the product’s inherent risks, balancing innovation with patient safety. By 2025,…