Combination products are integral to the healthcare system and play an increasingly important role in patient safety and medicinal usability, enhancing therapeutic benefits and improving outcomes.

According to analysis, the drug-device combination market was valued at US$127.8 billion in 2022 and it is predicted to grow at a compound annual growth rate of 8.9% between 2023 and 2030.

While combination products have been available for many years, advances in technologies, as well as the need for ‘user-friendly’ delivery of medicines, have led to an increase of these types of products globally and to a new generation of combination products.

Today, combination products have gone well beyond simple drug-release delivery systems, such as drug-eluting stents, to now offering intelligence and analytical capabilities that have the potential to reshape medicine. These include wearable sensors, 3D-printed implantable modules and digital drugs offering real-time monitoring.

Australia’s Combination Pathway

Australia’s Therapeutic Goods Administration (TGA) recently published its updated guidance on combination products and what it refers to as “boundary” products as a means to give sponsors and manufacturers greater clarity on the category and pathway for their therapeutic goods.3

The 2023 guidance updates the 2005 guidance, providing more context around what combination products are as well as additional considerations, given that much has changed in the market in the past 18 years.

In its guidance, the TGA defines combination products as those with components that have more than one therapeutic effect, for example, medicine-medical device combinations and medical devices that incorporate or are used to administer a medicine. Boundary products are defined as those that have characteristics from two or more categories and for which the appropriate regulatory pathway is not necessarily obvious.

In addition to the guidance, in April 2024 the TGA provided a further update with examples of boundary and combination products and their product category.4 This provides manufacturers and sponsors with information on how the agency is likely to regulate common boundaries and combination products. As the TGA makes further determinations on these products, it is likely that examples will continue to be updated.

How the agency regulates boundary products will depend on their principal therapeutic effect, therapeutic claims and stated intended use. Boundary products can include products that contain medicinal substances that work in an ancillary way, which, depending on their therapeutic effect, may be regulated as medicines. Examples include alcohol swabs and disinfectants with antiseptic claims that may be classified as medicinal products, and nasal decongestion products and eye lubricants that, depending on the mode of action, may be a medical device or a medicinal product.

In Australia, the way combination products are regulated depends on the primary mode of action (PMOA) for achieving their therapeutic effect, as well as the primary intended purpose. Drug device combinations may be regulated as either medicines or medical devices and would therefore be registered as such.