If you follow the CTN mechanism, the requirements are much less. We did this for a Phase I study recently and it worked out well as a means to rapidly get into the clinic.
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Richard Shansky PhD
Executive Director, Regulatory Affairs-CMC
Cambridge MA
United States
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Original Message:
Sent: 07-Jul-2020 08:51
From: Vincent Benn
Subject: CTA in Australia
What are the minimum requirements for obtaining authorization to initiate a Phase 1 study in Australia?