The use of genetically modified (GM) plants to synthesize proteins that are subsequently processed, regulated and sold as pharmaceuticals challenges two very different established regulatory frameworks, one concerning GM plants and the other covering the development of biotechnology-derived drugs.  Within these regulatory systems, specific regulations and guidelines for plant-made pharmaceuticals (PMPs) ? also referred to as plant-derived pharmaceuticals (PDPs) ? are still evolving.  The products nearing commercial viability will ultimately help to road test and fine-tune these regulations, and might help to reduce regulatory uncertainties.  In this review, we summarize the current state of regulations in different countries, discuss recent changes and highlight the need for further regulatory development in this burgeoning, new industry.  We also make the case for the harmonization of international regulations.