A CTD application for a generic medicine with clinical data…
A CTD application for a generic medicine with clinical data includes data supporting two different indications. In Module 5, the applicant provides:• A single, large, combined clinical study report file containing all studies across both indications,• No separation into synopsis, main body, and appendices,• Appendices embedded inconsistently within the document rather than structured according to recognised standards. During lifecycle management, one study needs to be updated due to revised statistical analyses. It is, however, difficult to replace only the affected sections. Which of the following best describes the key deficiencies in relation to CTD granularity of the application?