Other Facilitated Registration Pathways

ACCESS Consortium

The ACCESS Consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements. The consortium explores opportunities to share information and work in areas such as biosimilar products, complementary medicines, generic medicines, new prescription medicines, medical devices and information technology. The Consortium consists of health regulatory agencies from the Therapeutic Goods Administration (TGA) of Australia, the Health Products and Food Branch (HPFB) of Health Canada, Canada, the Health Sciences Authority (HSA) of Singapore, Swissmedic, Swiss Agency for Therapeutic Products, of Switzerland and the Medicines and Healthcare products Regulatory Agency (MHRA), of the United Kingdom. 

Project Orbis is a framework for concurrent submission and review of oncology products among international partners, organized by the US FDA Oncology Center of Excellence (OCE). Project Orbis was initiated in May 2019.