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 information of the medicine but supplied and obtained separately.

The primary focus of the guideline is integral DDCs under Article 1(9) of the Regulation (EU) 2017/745 on medical devices, as these are currently more commonplace. It covers devices intended to administer a medicinal product, where the device and medicine form a single integral product intended exclusively for use in the given combination and which is not reusable. The guideline notes that these are typically used for measuring, metering or delivery functions.

The guideline focuses on:

  • General considerations that will apply to the registration of all DDCs, including applicable standards (Ph.Eur. requirements and European and ICH guidance take precedence over ISO standards), the submission of data and format of the dossier, justification for use of platform technologies and the relevance of obtaining scientific advice.
  • Specific guidance on what information should be provided on the product, including description and composition, pharmaceutical development, manufacture, control of drug product, container closure system and stability.
  • Identifying adventitious agents and providing information on the assessment of risk with respect to potential contamination.
  • Requirement for DDC marketing authorisation applications to include evidence of conformity of the device part of the product with the relevant general safety and performance requirements (CE marked where available).
  • Data requirements that should be provided as part of marketing authorisation application for non-integral DDCs where the device element it separately supplied and obtained.
  • Incorporation of DDCs in clinical development and clinical trials.
  • Lifecycle management in relation to any changes to medical devices and/or device components within DDCs.
  • The possibility and provision of alternative approaches for emerging technologies.

It is intended that this guideline will increase transparency and consistency of information in regulatory submissions, reducing work for all stakeholders and ultimately improving patient safety.

The deadline for submission of comments on the draft guideline is 31 August 2019, with it scheduled to be finalized prior to the EU Medical Devices Regulation, Regulation (EU) 2017/745, coming into force on 26 May 2020.