The challenges of the CMC regulatory process for drug/device combination products are getting increasing attention in Europe as industry and regulators join in the search for clearer and more efficient communication channels and regulatory procedures.
At issue is the control and regulatory oversight of the interplay between the different components of a combination product, which can have a significant impact on both the safety and efficacy of the medicine for the patient.
The increasing complexity of this interplay in the biotech product context is among the factors fueling the need for a better understanding between regulators and industry in Europe of what needs to be communicated and how that communication should take place. In focus are the hurdles in the current European regulatory processes to this communication and what guidance and adjustments are needed to overcome them.
The regulatory oversight of the drug/device interplay and the meshing of the separate regulatory gears in the two arenas has been a front-burner issue at conferences in the US for a number of years, and the FDA Office of Combination Products (OCP) has played a very active role in driving a more efficient coordination between the drug, biologic, and device review centers at the agency.
But the related dialogue has been heating up in Europe as well, where the disparate drug and device regulatory structures, processes and jurisdictions create additional complexities, and where an OCP-equivalent coordinator is not in place.