kombinasjonsproduktene

Kombinasjonsproduktene, or combination products, are medical devices that combine a drug or biologic with a medical device component. This integration aims to improve therapeutic outcomes, enhance patient adherence, or simplify drug delivery. The device component is integral to the product's function and cannot be separated from the drug without compromising its intended use. Examples include pre-filled syringes with needles, metered-dose inhalers, and auto-injectors.

The regulatory framework for combination products can be complex, as they fall under the purview of both drug and device regulations. In many countries, a lead regulatory center is designated to oversee the review and approval process, ensuring that both the drug and device aspects are adequately evaluated. The classification of a combination product is determined by its primary mode of action. If the primary mode of action is achieved by the drug, it is regulated as a drug. If it's achieved by the device, it's regulated as a device. If neither alone achieves the primary mode of action, it's regulated based on the mode of action of its most critical component.

Development of combination products requires close collaboration between pharmaceutical and device engineers. Considerations include material compatibility, stability of the drug within the device, and user-friendliness. The benefits of combination products often outweigh the challenges, leading to improved patient care and more efficient healthcare delivery. They are increasingly prevalent in areas such as chronic disease management, self-administration of therapeutics, and targeted drug delivery.