Guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women

We have adopted this International Scientific Guideline - EMEA/CHMP/021/97 Rev. 1.

Last updated

3 June 2024

About this guideline

Overseas effective date: 1 May 2006

Replaces: CPMP/EWP/021/97 (adopted by TGA 15 December 2000)

Categories: Clinical efficacy and safety | Genito-urinary system and sex hormones

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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