Navigating the Complex Landscape of Combination Product Regulations

Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano spoke at the Combination Products Summit. Source: Michele G. Sullivan

Insights From Combination Products Summit

The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because different countries have their own definitions and requirements for these products. This lack of uniformity complicates the application process, adding layers of complexity and burdening manufacturers.

Despite some initial efforts towards regulatory harmonization, substantial progress remains elusive. Regulatory bodies like the Global Harmonization Task Force and the Asia-Pacific Economic Cooperation have attempted to streamline these standards, but the sheer complexity has stifled these initiatives. More recent efforts by ASTM International and ISO have made some headway, yet full alignment is still a distant goal.

The consequences of these fragmented regulations are profound. They not only hinder the development of innovative products but also put manufacturers at a competitive disadvantage globally. Experts at the summit emphasized the urgent need for clearer and more aligned regulatory frameworks. Such cohesion would not only support the development of advanced combination products but also ensure that these innovations can reach markets worldwide more efficiently.

As we navigate this intricate regulatory environment, it is crucial for industry stakeholders to advocate for harmonization. By working towards more unified regulations, we can foster an ecosystem that supports innovation and ensures that cutting-edge combination products are accessible to those who need them most.

We look forward to the outcomes of the 2024 Summit and hope to see significant progress in regulatory alignment and the impact it will have on the industry.

Check out the full article here.

For information on the upcoming 2024 Combination Products Summit, click here.