Industry and regulators in the US and Europe are wrestling with how best to interpret and communicate drug quality-by-design (QbD) concepts, device design controls (DC) and overall final product risk management in the drug/biologic/device combination product context.
At issue are the CMC development, control strategy, and submission requirements for bringing combination products (CPs) to the market and making post-approval changes – and the enforcement backlash if patient health is jeopardized when the expectations are not met.
The dialogue around the industry/regulator communication challenges in melding the pharmaceutically-oriented ICH guidance with the current ISO standards and expectations for devices has been prominent at quality regulatory conferences and forums recently, and will continue apace as the US and Europe work to further refine their CP regulatory expectations.
The communication process between industry and regulators rests, in turn, on how well information is flowing within CP sponsor companies – between departments and to senior management – and with their contractors and patients.
The linkages between risk management and control strategies become more challenging in the CP context with the different philosophies, procedures, terminology and global regulatory requirements that come into play for drugs and devices.
Further complicating the picture – and heightening the urgency of the dialogue – are the wide variety of advanced technologies that are being integrated into both the drug/biologic and device sides in the combinations.