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Guideline on clinical investigation of medicinal products in the treatment of depression

We have adopted this International Scientific Guideline - EMA/CHMP/185423/2010 Rev. 2.

Last updated

About this guideline

Overseas effective date:  1 December 2013

Replaces: CPMP/EWP/518/97 Rev 1 (adopted by TGA 7 August 2002); and Concept paper EMEA/CHMP/EWP/484366/2009 on this topic (provided for information 23 February 2010)

Categories: Clinical efficacy and safety | Nervous system

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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For more information see International scientific guidelines adopted in Australia.

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