Long-Term Follow-Up and Patient Registries Regulatory Strategy in 2023 – Playbook 10 Long-Term Follow-Up and Patient Registries Regulatory Strategy in 2023 – Playbook 10 Step 1: Understanding the Importance of Long-Term Follow-Up Long-term follow-up (LTFU) and patient registries play a crucial role in the assessment of the real-world safety and efficacy of Advanced Therapy Medicinal Products (ATMPs). These mechanisms are vital for gathering post-marketing data that can substantiate clinical findings observed during the initial trials. The necessity for LTFU is highlighted in various regulations and guidelines, such as those outlined by the FDA and EMA. Understanding the significance of LTFU…