The development of pharmaceuticals, and health interventions in general, has taken on global dimensions regarding the science, politics and economics of medicines development and marketing. The fundamental reasons for these changes are much larger than pharmaceutical research itself. The reasons include political changes (in certain geographical regions and countries), growing economies with an increased potential to produce and deliver products locally, and the ever increasing reach of communications and science across national and cultural boundaries. Add to this a swell in basic pharmaceutical research (as well as in areas such as genetics and stem cell science), in places like India, China, Brazil and South Korea, alongside increased investment and capacity in manufacturing, and the development of pharmaceutical medicines takes on new proportions that could not have been foreseen in the 1990s. At the same time we see an increased public awareness and concern regarding ethics and transparency in clinical research around the world. In 2005 the Vioxx® 1 case in the US stirred public attention regarding responsibility and accountability in the development and marketing of medicines. This, combined with increased public scrutiny regarding the safety and oversight of medicines, has led to greater scrutiny by the media and consumer groups with regard to the processes of researching and delivering medicines. In addition, the increased amount of research being conducted in places such as Eastern Europe, Asia and Latin America has led to a growing call for improved ethical review and government oversight in all regions and countries where pharmaceutical research is conducted. The globalisation of, and increased scrutiny of, medicines development has brought with it demands for increased transparency. A major issue in 2005 was the implementation of procedures by different parties for the registration of clinical trials on pharmaceuticals. This came about as a direct result of the 9 September 2004 statement by the International Committee of Medical Journal Editors (ICMJE) requesting the public registration of clinical trials prior to their commencement. The ICMJE request was quickly followed by similar positions taken by the pharmaceutical industry, as well as by public and academic institutions and researchers. The pharmaceutical industry responded in a rapid and concerted manner, as represented in the position papers it put forward through the International Federation of Pharmaceutical Manufacturers Associations and its principal associations in the US, Europe and Japan. Not-for-profit and public-based research institutions, such as the European Clinical Research Infrastructures Network (ECRIN) and the Canadian Institutes of Health Research (CIHR), also took strong positions on the need for making available information on clinical trials to the research community as well as to patients’ groups. These actions are now being consolidated through the World Health Organization’s 2005 initiative establishing an International Clinical Trials Registry Platform. In 2005 we have also seen an increased interest in the promotion of good clinical practice (GCP) as a means toward developing public accountability – largely as a response to the growth and impact of medicines development. Within this expansion of GCP, both in terms of the areas of research within which GCP is applied (e.g. clinical trials registration, the responsibilities of the regulatory authority) as well as in geographic areas, we see a specific focus on improved ethical review and government oversight – both within and outside of the traditional International Conference on Harmonisation (ICH) regions. Countries such as South Korea, China, Thailand and Indonesia have taken major steps toward improving the quality of ethical review committees. Some