The Clinical Overview (CLO) is an important part of the Common Technical Document (CTD), especially in the EU. It provides an invaluable resource for Medical Assessors to familiarize themselves with the scope of, the Applicant’s rationale for, and the critical issues in the clinical development program. It should be a truly critical, yet appropriately supportive, assessment of the data that often also has to justify the proposed Summary of Product Characteristics (SmPC).