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EBE Reflection Paper: Medicinal product incorporating a drug delivery device component: An Industry Perspective on developing an efficient, ‘End to End’ Control Strategy

12 Jun 2019

A cross-industry working group within EBE (European Biopharmaceutical Enterprises) has recently 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 working group developed a reflection paper which provides an Industry perspective on the development of a control strategy to support a single integral medicinal product containing a drug delivery device component.

EMA’s Quality Working Party and Biologics Working Party have communicated in a 2017 concept paper their intent to develop a guideline on quality aspects of the dossier requirements for drug-device combination (DDC) products for marketing authorisation applications (MAA’s), 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.

This paper outlines how existing quality guidance can be used as a framework for DDC product control strategy development and seeks to demonstrate that, if an ‘end-to-end’ approach to drug product control has been applied, an acceptable Pharmaceutical Quality System (PQS) is in place and an appropriate risk profile has been established, batch releases need not rely wholly on end product testing. It is acknowledged that additional guidance on quality content may be necessary, however, the adaption and integration of drug and device dossier content for DDCs should be possible with minimal disruption to existing ‘best practice’.

This paper is intended as a companion piece to the EBE reflection paper: ‘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’, published in January 2018.

Taken together, these two EBE Reflection Papers aim to encourage the discussion between the industry and the EMA on the identified issues.

2019-06-19T08:13:50+00:00June 12, 2019|