ABSTRACT
The general concept of “Combination Product” has been adopted in many regions around the world to refer to medical products that consist of a combination of two or more regulated products such as a drug, biological product, or device. It should be noted, however, that the official regulatory definitions and terminologies can vary from one jurisdiction to another, resulting in some products being categorised differently in certain jurisdictions compared to others. Nonetheless, ensuring that combination products are effectively managed throughout their product lifecycle is critical to long term success in the market. Navigating the complex regulatory frameworks of different countries and regions is undoubtedly a costly investment in time and resources for the combination product industry and stakeholders. This chapter provides an overview of: (i) the evolving global combination product regulatory environment, (ii) global harmonization efforts, and (iii) review of regulatory evolution and approach for individual countries on how to obtain and maintain market access. Comparative overview of individual countries/regions includes: United States, European Union; United Kingdom/Great Britain and Northern Ireland; Australia; Canada; Japan; China and Rest of World. The chapter concludes with common challenges faced given regulatory discrepancies and lack of well-defined regulatory pathways in many jurisdictions, and harmonization opportunities to foster future growth and innovation, and expedite market entry, with the common goal of ensuring availability of high-quality and safe new products to promote public health .
