The New Written Summaries to Be Attached to the Expert Report — Concepts and Requirements

Abstract

This paper covers recent revisions to the European Notice to Applicants. The structure of the notice and new requirements are covered. Written summaries with tabular overviews should now be attached to expert reports for certain categories of products. These summaries provide a summary of the data and are used by regulators to prepare their assessment reports. They should facilitate the assessment task and speed up the application process.