Position Paper

EBE reflection paper on “Medicinal product incorporating a drug delivery device component: An Industry Perspective on the EU marketing application technical requirements, regulatory review process and post-approval device related change assessment”

15 Jan 2018

Within the European Biopharmaceutical Enterprises (EBE), a working group focused on EU specific topics relating to those integral combination products, which are regulated as medicinal products but which contain a drug delivery device component.

The EMA Quality Working Party and Biologics Working Party communicated in a recent concept paper(*) their intent to develop a guideline on quality aspects of the dossier requirements for Drug Device Combination (DDC) products for marketing authorization applications (MAAs), line extension applications and variations to show that the combination has been appropriately designed and controlled and can be used correctly in the intended clinical situations.

EBE developed a reflection paper with thematic mirroring the scope of the above mentioned EMA concept paper and covering as well, the impact of the Medical Device Regulation (MDR) entering into force in May 2020 and more specifically of Article 117.

The EBE Reflection Paper aims to encourage the discussion between the industry and the EMA on the identified issues.

*Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, EMA/CHMP/QWP/BWP/661488/2016, November 2016