A sponsor submits a dossier for regulatory review in South A…

A sponsor submits a dossier for regulatory review in South Africa with the following findings during inspection: Trial sites used trained pharmacists to conduct screening procedures under Principal Investigator oversight, but delegation logs were inconsistently updated. Biological samples were stored at correct temperatures, but calibration logs for freezer monitoring devices were missing for a 2-week period. Adverse events were recorded, but serious adverse event reporting to the sponsor was delayed by 72 hours in several cases. Statistical analysis plan was finalised after database lock but before unblinding. Source data verification was performed on 60 % of records instead of the planned 100 % due to staffing limitations. Which is the most serious regulatory concern?

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?