applica

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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.

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