Clinical Overview

The Clinical Overview is an important part of the Common Technical Document (CTD), especially in the EU. If written well, it should provide 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. However, it is not easy to write a truly critical, yet appropriately supportive, assessment of the data that often also has to justify the proposed Summary of Product Characteristics (SmPC), especially if an indigestible, over-long document is to be avoided.