Understanding M3, M4 and M5 Studies

In the CTD and eCTD dossier formats, m3, Safety module 4 (pertaining to non-clinical studies), and Efficacy module 5 (pertaining to clinical studies) are described in depth. The SAHPRA, and mostly ICH guidelines on safety and efficacy correlate to this section. Deep dive into the requirements of each node and when it is appropriate or not to add or omit certain nodes.