The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released new guidelines on medical cannabis for companies wishing to operate in the sector, hinting at a change in the government's attitude.
The new guidance from the MHRA, in conjunction with the Home Office, provided the steps for firms that "do not already hold the necessary authorisations" to begin producing cannabis-based medicines and active pharmaceutical ingredients (APIs) in the country.
Step-by-step guidelines were part of new "joined up approach" from the two departments in order to approve new companies.
This followed an influx of "companies with no previous pharmaceutical experience [...] entering the pharmaceutical sector solely to cultivate, process and manufacture cannabis-based products destined to be used as medicines," the MHRA said.
Previously, it was typical that companies applying to manufacture and handle controlled drugs already had existing MHRA licences to cover their manufacturing activities and could apply to the Home Office for authorisation to handle controlled drugs.
But now there was a "conundrum" as the requirements from MHRA and Home Office often got in the way of each other, the MHRA said, using a picture of a chicken and an egg.
The UK market is still modest compared to the North American and other markets overseas, with medicines derived from cannabis only made legal in Britain in 2018 and a legal grey area only cleared up in 2020 when the Financial Conduct Authority allowed UK-based medicinal cannabis companies to list their shares publicly.
There are several UK companies that are already registered and up and running in the sector, including Grow Group PLC, Hellenic Dynamics PLC and Northern Leaf .