Investigation of drug interactions - Scientific guideline

This document provides advice and recommendations on how to evaluate the potential for drug-food and drug-drug interactions for medicinal products (including herbal medicinal products) and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

Keywords: Interaction, metabolism, inhibition, induction, transport, enzyme, transport protein, transporter, absorption, food, distribution, physiologically based pharmacokinetic (PBPK), herbal, summary of product characteristics (SmPC), pharmacodynamic

Current effective version - Under revision

Guideline on the investigation of drug interactions - Revision 1

Adopted Reference Number: CPMP/EWP/560/95/Rev.1 Corr.2**

Document history - Revision 2

Concept paper on a revision of the guideline on the investigation of drug interactions

Draft: consultation closed Consultation dates: 07/04/2017 to 30/06/2017 Reference Number: EMEA/CHMP/694687/2016 Summary:

The first revision of the Guideline on the investigation of drug interactions (CPMP/EWP/560/95/Rev. 1 Corr. 2**) was adopted by the CHMP in June 2012. This concept paper proposes a further update to reflect recent scientific knowledge and experience in applying the guideline since it came into force.

Document history - Revision 1 (current)

Guideline on the investigation of drug interactions - Revision 1

Adopted Reference Number: CPMP/EWP/560/95/Rev.1 Corr.2**

Overview of comments received on guideline on the investigation of drug interactions

Reference Number: EMA/CHMP/EWP/125211/2010

Draft guideline on the investigation of drug interactions

Draft: consultation closed Consultation dates: 22/04/2010 to 31/10/2010 Reference Number: EMA/CHMP/EWP/125211/2010

Concept paper/recommendation on the need for revision of (CHMP) note for guidance on the investigation of drug interactions

Reference Number: EMEA/CHMP/EWP/297931/2008

Document history - First version

Note for guidance on the investigation of drug interactions

Adopted Reference Number: CPMP/EWP/560/95 Legal effective date: 01/06/1998