The European Medicines Agency (EMA) publishes background documents on excipients for inclusion in the label and package leaflet of human medicines.

An excipient is a constituent of a medicine other than the active substance.

Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), EMA set up the CHMP Excipients Drafting Group (ExcpDG) in 2011.