De-Risking The Transition From Vial To Drug-Device Combination Product

This article focuses on combination products where a drug or biologic is the primary component and is either already in a vial or being considered for vial packaging versus a combination product. These products are typically classified as Single Entity or Co-Packaged.

For submissions in the United States, the regulatory pathway depends on the primary mode of action:

• Drug-led products are filed through the Center for Drug Evaluation and Research (CDER).
• Biologic-led products are filed through the Center for Biologics Evaluation and Research (CBER).

In the European Union, the approach differs:

• Medicinal substances with an integral medical device (similar to a Single-Entity in the US) are submitted to the European Medicines Agency (EMA). This requires either a Notified Body opinion or a CE Mark for the device component.
• Non-integral products require two separate submissions: one to the EMA for the medicinal component and another to a Notified Body for the device component to obtain a CE Mark.