The framework for regulating cannabis as a pharmaceutical product varies widely across the world, though increased clinical research into cannabis products means more approvals are likely under any scenario.
“It’s currently a complex patchwork of approaches,” Michael Craig, a principal consultant at Parexel International, said during a session on cannabis regulatory challenges and harmonization at RAPS 2020 Convergence. “That is the embodiment of it being borne out by national legislation rather than an overarching EU or European Medicines Agency framework.”
Though Craig was speaking specifically of the approaches within the European Union, the same is true in the United States, where states are passing medical marijuana legislation independent of federal action. Additionally, Canada has its own regulatory framework for defining and governing medicinal cannabis products.
Under international drug control treaties, the use of cannabis in the European Union is limited to scientific and medical purposes, and medicines are authorized through a number of different procedures. Also, individual member states have different schemes for allowing patients to access unapproved medicines under medical supervision, according to Craig…