Gene Therapy Regulatory Requirements Explained: Complete Guide for FDA, EMA, and Global Submissions Global Regulatory Requirements for Gene Therapy: A Step-by-Step Guide for Compliance and Patient Safety Introduction to Gene Therapy Regulatory Requirements Gene therapy involves the introduction, removal, or modification of genetic material within a patient’s cells to treat or prevent disease. As a core category of Advanced Therapy Medicinal Products (ATMPs), gene therapies hold transformative potential for rare diseases, oncology, and inherited disorders. However, due to their complexity, regulators such as the FDA, EMA, and CDSCO impose rigorous regulatory requirements to ensure safety, efficacy, and quality. By 2025,…