CRED Practical Document Writing and Management

CTD granularity

CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 & 5 are intended to be common for all regions. In July 2003, CTD became mandatory format for new drug applications in the EU and Japan, and the strongly recommended

Led to harmonised electronic submission

Enabled implementation of good review practices

Revolutionised regulatory review processes

2.4

format of choice for NDAs submitted to the FDA, US

2.5

2.3

2.6

2.7