Development of block-copolymer-micelle medicinal products - Scientific guideline

This document provides basic information for the pharmaceutical development, and non-clinical and early clinical studies of block-copolymer micelle drug products created to affect pharmacokinetics, stability and distribution of incorporated or conjugated active substances in vivo. It is a joint reflection paper of the Ministry for Health, Labour and Welfare and the European Medicines Agency.

Keywords: Block copolymer micelles, nanomedicines, non-clinical, first-in-human studies, drug development

Current version

Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products

Adopted Reference Number: EMA/CHMP/13099/2013

Document history

Draft joint Ministry of Health, Labour and Welfare / European Medicines Agency reflection paper on the development of block-copolymer-micelle medicinal products

Draft: consultation closed Consultation dates: 01/02/2013 to 01/07/2013 Reference Number: EMA/CHMP/13099/2013 Summary:

This paper provides basic information for the pharmaceutical development, and non-clinical and early clinical studies of block-copolymer-micelle drug products created to affect the pharmacokinetics, stability and distribution of incorporated or conjugated active substances in vivo.