Clinical efficacy and safety guidelines: genitourinary system and sex hormones
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
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The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the genitourinary system and sex hormones help medicine developers prepare marketing authorisation applications.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI)
- Clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women
- Clinical investigation of medicinal products in the treatment of urinary incontinence
- Clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency
- Clinical investigation of steroid contraceptives in women