Although it is the goal of most major pharmaceutical companies to achieve global development for new medicines with simultaneous submission of the regulatory dossier in the three main ICH regions, there are a number of scientific and regulatory hurdles that can impede this strategy. The CMR International Institute convened this Global Drug Development Workshop in Tokyo, Japan, in May 2004 to explore the issues experienced by industry and regulatory agencies and discuss these in Syndicate Groups. The recommendations from the syndicate discussions explored short and medium term actions for facilitating global drug development within the current R&D paradigm but also made several far-reaching recommendations for a new paradigm for the development and review of new medicines.