The European Medicines Agency wants the EU to require better clinical data to support marketing authorization applications (MAAs) for drug-device combination products.
Because of the wide variety of combination products and differences between EU device and drug legislation, the data supplied with MAAs are often inconsistent and incomplete, the EMA said, in a concept paper.
A related problem is that EU regulators sometimes do not fully account for the characteristics of the drug component of a combination product where the drug and device are provided separately, the EMA said.
There has been a sharp increase in the number of MAAs, especially for commercially available novel devices with automated functions that can be used at home, the agency said. This has increased the potential for errors and indicates a need for better clinical data on safety and effectiveness.
The EMA called for requiring clinical data to be submitted with MAAs showing that combination products have been appropriately designed and can be used correctly. Device complexity, intended clinical settings, and targeted patients and caregivers should be taken into account. Separate data requirements may be required for integrated combination products compared to those in which the device is a stand-alone component.
The guidance should consider the information to be included in product literature, such as patient information leaflets and labeling. It should also include requirements when a specific medical device must be used with a drug – such as nebulizers or anesthetic delivery equipment – but where the devices are available separately, and often from a different manufacturer.
The concept paper is open for public comment for three months. EMA will then issue draft guidance with a six-month comment period. The agency has not yet set a timetable for release of final guidance.