Combination products have existed in both the EU and the US markets for several decades, but regulations for combination products are relatively recent, and in certain markets they do not yet exist. Furthermore, regulatory submission formats specific to combination products have not yet been developed.
The cross-sector collaboration among companies in the life sciences industry has increased over the years, leading to an ever-growing number of products combining medical devices, drugs and/or biologics.
Currently, regulations for medical devices, biotechnology and pharmaceuticals vary significantly. Navigating the regulation of these often unique products has long been a challenge for both regulators and industry that goes well beyond products consisting of either devices, drugs or biologics alone. And the degree of innovation and diversity involved in combination products is much greater still.
Some challenges for combination products are similar in the EU and the US, yet others are specific to the two markets. Our free whitepaper available below examines the regulatory challenges for combination products in the EU and the US, and the possible ways in which to manage them. Can’t see the whitepaper? Simply subscribe to our Knowledge update for full access to all content from our MedTech experts.