Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products

We have adopted this International Scientific Guideline - EMEA/CHMP/SWP/28367/07

Last updated

6 January 2025

Overseas effective date: 1 September 2007

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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