The growth pace for the development of cell and gene therapies in the Asia-Pacific region has been very rapid in recent years, only second to North America. Regulators recognize this emerging trend in dynamic research and development and have started developing regulatory frameworks and pathways to accommodate it. This session will be devoted to the comparison and discussion of the regulatory landscape for advanced therapies in different markets within the Asia-Pacific region and the marketing authorization procedures available in these markets as well as include perspectives from Japanese and Taiwanese regulators.