Post-Marketing Surveillance of ATMPs Explained: Global Compliance Guide for FDA, EMA, and CDSCO Ensuring Safety Through Post-Marketing Surveillance of ATMPs: A Regulatory Affairs Guide Introduction to Post-Marketing Surveillance for ATMPs Advanced Therapy Medicinal Products (ATMPs) — encompassing gene therapies, cell therapies, and tissue-engineered products — often demonstrate unprecedented efficacy but carry significant long-term risks. Because these products may involve genetic modification, immunogenicity, or integration into host tissues, regulators demand extensive post-marketing surveillance (PMS). This ensures that adverse events, delayed risks, and real-world outcomes are effectively captured and managed. Agencies such as the FDA, EMA, and CDSCO mandate structured pharmacovigilance, risk…