Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts who spoke at the 2023 Combination Products Summit held by the AFDO/RAPS Healthcare Products Collaborative.
Despite some preliminary efforts at harmonization and good — but thus far unfulfilled —intentions to undertake more substantial changes, the regulatory landscape for these products remains a confusing maze of requirements that often frustrate companies. Although medical products are typically regulated by a country’s primary medical regulatory agency, decisions on combination products are often based on either the therapeutic agent or the device itself, depending on the intended therapeutic action. Additionally, different countries define combination products differently, making it tough to know exactly how to file an application for marketing authorization…
