Use of cocrystals of active substances in medicinal products - Scientific guideline

This reflection paper applies to human and veterinary medicines.

This document aims to reflect the current thinking of the CHMP and CVMP regarding different aspects concerning the use of cocrystals of active substances in medicinal products for human or veterinary use.

Keywords: Cocrystals, salts, hydrates, solvates, polymorphic forms, solid state, active substance

Current version

Reflection paper on the use of cocrystals of active substances in medicinal products

Adopted Reference Number: EMA/CHMP/CVMP/QWP/284008/2015

Document history

Reflection paper on the use of cocrystals of active substances in medicinal products

Adopted Reference Number: EMA/CHMP/CVMP/QWP/284008/2015

Overview of comments received on 'Reflection paper on the use of cocrystals and other solid state forms of active substances in medicinal products’

Reference Number: EMA/CHMP/CVMP/QWP/284007/2015

Draft reflection paper on the use of cocrystals and other solid-state forms of active substances in medicinal products

Draft: consultation closed Consultation dates: 31/07/2014 to 31/10/2014 Reference Number: EMA/CHMP/CVMP/QWP/136250/2014 Summary:

The content of this reflection paper represents the current thinking of the Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party concerning recent scientific developments on solid-state forms, in particular cocrystals. The reflection paper provides guidance concerning the legal basis and submission requirements for cocrystals.