Chapter 28: Evolving Regulatory Landscape for Drug-Device Combination Products: Europe and Other Major Market Perspectives

Abstract

This chapter considers the changing regulatory framework for drug-device products in other major markets outside the USA, with specific focus on Europe. The chapter explores the evolving requirements across major regions, which have been driven by a want to converge and harmonize regulation and guidance, and specific international forums which have formed that are driving harmonization be examined. This chapter highlights the more recent overhaul in regulations in Europe. This has resulted in more rigorous scrutiny of medical device manufacturers and greater emphasis on patient safety. Specifically, it introduces new requirements for pharmaceutical companies developing drug-device products, requiring the need to obtain a third-party opinion on the medical device element as part of the product registration. Finally, the chapter considers industry perspective on harmonization efforts, the manufacturers’ evolving role to maintain compliance and life cycle management and how developments in specific guidance and standards for drug-device products could further facilitate global harmonization and convergence across major regulatory regions.