Journal Articles

Combination products (CPs) are at the forefront of medical innovation, merging drugs and devices to improve patient outcomes. CPs can be classified into several types: integral drug-device combinations (iDDCs), medical devices containing ancillary medicinal substances, medicinal products packaged with a medical device (so called co-packaged products), and medicinal products, where the product information refers to a specific medical device obtained separately from the medicinal product (reference products). This article focuses on iDDCs, where a medicinal product and device part form an integral combination and where the action of the medicinal product is principal. These products are marketed as a

This article assesses some of the most notable clinical developments in recent years, where the next generation of research is likely to be heading in the coming years, how the regulatory authorities are responding to these advances, and how these developments and regulatory proposals are likely to impact patient access.

The eCTD v4.0 standard has been available to be used for submissions to any ICH-participating regulatory agency since 2015, when it reached Step 4 in the International Council on Harmonisation (ICH) process. However, 10 years later, only Japan and the US have begun optional use of the new version.