Melatonin product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of melatonin.

Keywords: bioequivalence, generics, melatonin

Abbreviations: 

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current version

Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/226444/2025

Document history

Draft melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 25/09/2025 to 31/12/2025 Reference Number: EMA/226444/2025 Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Overview of comments received on ‘Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance’ (EMA/CHMP/226444/2025)

Reference Number: EMA/32320/2026