Guideline on clinical investigation of steroid contraceptives in women

We have adopted this International Scientific Guideline - EMEA/CPMP/EWP/519/98 Rev 1.

Last updated

4 June 2024

About this guideline

Overseas effective date: 1 January 2006

Replaces: EMEA/CPMP/EWP/519/98 (adopted by TGA 19 April 2001)

Categories: Clinical efficacy and safety | Genitourinary 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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