The complex network of health product research, development, manufacturing and commercial distribution continues to expand globally. Different regulatory requirements must be taken into account when dealing with international development. The focus of this symposium will be to elaborate on the varying regulatory requirements with respect to the following: Specific EU rules for innovative therapies, the differences with US regulatory requirements and some clues on how to build a development plan that can support an international development; the current Chinese regulatory environment, challenges on clinical trial design, and on site and patient management; and recent efforts in the developing world (including sub-Saharan Africa) aimed at regulatory capacity as well as streamlining and strengthening regulatory processes for the regulation of medicines globally.