Combination products (CPs) are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Innovation in drug and biologic therapies along with technological advances in the design and development of delivery devices has resulted in a significant increase in available combination products. In parallel, there is an increasing demand for patients to be able to self-administer their therapies at home. This results in a reduced number of clinic visits, which appeals to both healthcare providers and patients alike. This trend is expected to continue as technological advances merge product types which results in blurring of the historical lines of regulatory separation.
Since combination products involve components that would normally be regulated under different types of regulatory authorities, they raise regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control and post-approval modifications.
