Innovation in science, medicine and technology are moving at a fast pace creating new types of therapies, and new ways of administering and monitoring those therapies, creating new types of combination products not encountered before. The current regulatory frameworks are being challenged by such developments and potential applicants of novel combination developments often struggle in identifying who to approach at an early stage for scientific and/or regulatory advice. Additional complexity is introduced by integrating or adding a digital component, which can vary from simple to more complex in function and value.
Whereas the US-FDA has the Office of Combination Products as a point of contact to facilitate review and provide clarification, the path in Europe is not as straightforward. However, in response to the anticipation of more complex combination products for which the regulatory pathway may not be easily assigned, EU Regulators have begun to strengthen their cooperation between medicines and devices authorities and to provide a forum for discussion on challenging products early in their development.
The session will provide an overview on the state of play of regulating combination products in light of the increasing use of digital components. With an expected increase in complexity of combination products in the future and thus requiring a more cross-discipline and expertise approach, the session will explore how to more effectively deal with new and emerging technology combinations from development to market approval and how best to involve different disciplines at the different stages.
Discuss existing provisions for review and approval of combination products.
Describe existing support mechanisms for the development of combination products and identify the unique challenges of pre-market and post-market requirements.
Explain different elements necessary to develop and market a digital combination product.