Medical use of cannabis and cannabinoids containing products – Regulations in Europe and North America

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

“…These constraints have also inhibited clinicians from exploring therapeutic value and severely limited patient access in most legislatures, with clinical application further blocked by the removal of Cannabis from pharmacopoeias in the 1970s [13, 14]. Until recently, neither of the two major central regulatory agencies which evaluate drugs, European Medicines Agency (EMA) and United States Food and Drug Administration (FDA), approved nor permitted marketing authorisations for Cannabis or Cannabis -related extracts [15]. Indeed, prior to June 2018, only two synthetic cannabinoid-based pharmaceuticals had been approved by the FDA, nabilone (Cesamet®) [16] and dronabinol (Marinol® and Syndros®) [17].…”

“…At the decentralised national level, 23 European countries have allowed authorisation of the oromucosal spray nabiximols (Sativex®) for multiple sclerosis-associated indications [15]. In Australia, medicinal Cannabis products were nationally rescheduled to a Schedule 8 Controlled Drug in November 2016.…”

“…A number of countries, including Israel, Canada, Germany, and the Netherlands, along with approximately half of the USA at the state level, have changed their regulations to allow patient access to medical Cannabis and related products [15]. At the decentralised national level, 23 European countries have allowed authorisation of the oromucosal spray nabiximols (Sativex®) for multiple sclerosis-associated indications [15].…”

“…Changes to domestic policy relating to medicinal Cannabis have occurred rapidly in a number of countries [15]. However, there is considerable confusion with regard to the legality and accessibility of these products both within and between legislatures [15].…”

“…However, there is considerable confusion with regard to the legality and accessibility of these products both within and between legislatures [15]. Marketed prescription and over-the-counter medicines approved by regulatory agencies, such as the EMA and FDA, are standardised and dosage-formulated products that have demonstrated quality, safety and efficacy for their intended use.…”