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 Workshop to explore the issues through presentations by industry and regulatory agency experts and discussions in Syndicate Groups. The recommendations from the syndicated 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.