Emerging guidelines for the regulation of plant-based drugs are being put into effect by the Pharma-Planta initiative.

Abstract

Rapid progress in recent years has brought plant-made pharmaceuticals (PMPs) out of the early
stages of research and into clinical trials; the first commercial medications for human use are projected to hit
the market in 2009. It is yet to be seen if PMP technology will be commercialized in Europe, although at
least one product has already entered phase II clinical testing. These new goods pose a threat to the existing,
convoluted regulations that control the creation of both genetically modified (GM) plants and "conventional"
medicines. Specific rules for the regulation of PMPs are now being drafted, and the areas of responsibility
amongst the several EU regulatory bodies are being mapped out. In this post, we'll go through some of the
challenges that have come up during the process of developing rigorous risk assessment and risk
management methods focused on health and environmental effect, all while cooperating with EU regulatory
agencies to provide adequate regulatory monitoring.