The New European Union Good Agricultural and Collection Practice Rules: Are Good Practices Good Enough if They Do Not Result in Batch-to-Batch Consistency?

Abstract

This article discusses the newly published European Union Points to Consider on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin (hereafter called European Union GAP). It explains what good agricultural and collection practice is good for and provides an overview of the topics regulated by European Union good agricultural and collection practice. Because European Union GAP does not provide rules for standardization, there is no guarantee that the medicines made from starting materials cultivated or collected under these rules will be fully reliable. Examples will be given on content variation in opium and ginkgo leaf. Proposals are made to include additional rules for standardization. An example of the application of rules for standardization in the production of cannabis for medicinal purposes will be described.