模块1 - 这不是CTD的一部分,也不是由ICH指南定义的。它包含特定的区域管理信息,例如申请表。
模块2 - 本节介绍了药物,并包括提交数据的关键摘要,包括例如质量总结,非临床概述和临床概述。
模块3 – This module contains the quality information for the drug substance, drug product and any relevant regional information. Module 3 is also referred to as the Chemistry, Manufacturing and Controls (CMC) section.
模块4 – This section contains safety information presented in non-clinical study reports.
模块5 – This contains efficacy information presented in the clinical study reports.