This online guide provides a framwork for researchers to help navigate orphan drug development offering detailed charts of the regulatory proccesses in europse, the US and Japan. ‘Building block’ fact sheets sumarise key concepts, organisations, and tools involved in drug development. Milestones show the stages a project needs to reach with checklists for what to do before and after each milestone. This video (https://www.youtube.com/watch?v=rXb8fDxE8Nk) introduces the guide in detail and has a helpful walk through of the website starting at 50.46.