EMA releases draft guidelines on drug-device combinations
On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline providing guidance on the quality dossier requirements for Drug-Device Combinations (DDCs) in the context of a marketing authorisation or post-authorisation application.
DDCs are human medicines that include a medical device. The guideline covers those devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product…