"The ICH agreement induced several revisions in This allows for a regulated mutual recognition of July 2001 and June 2003, to describe the preparation clinical data, which should signi fi cantly reduce of the CTD, enforced in April 2005. the number of useless duplications of clinical studies and consequently save development Module I: Regulatory information such as applica - resources (see Chapter 18). tion forms and information on attached documen - tation."