The European Medicines Agency (EMA) has published a draft ‘Guideline on the quality requirements for drug-device combinations’. The new document provides guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for a marketing authorisation application or a variation application.
Products covered include medicinal products which contain one or more medical devices as an integral part of the composition, as well as medicinal products for which one or more medical devices and/or device components are necessary for use of the medicinal product. The DDCs are also defined as integral to the medicinal product or non-integral (i.e. co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately).
The consultation is open until 31 August 2019.