Will MDMA be licensed in the UK by the end of this year?

It's a popular guessing game trying to work out when MDMA is likely to be licensed in various different countries (of course it already is in Australia). MAPS put in a New Drug Application (NDA) to the US FDA on 12th December to try to get MDMA-assisted therapy licensed for trauma treatment.  MAPS comment"The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively).  If approved by the FDA, the U.S. Drug Enforcement Administration (“DEA”) would be required to reschedule MDMA making it available for prescription medical use."  This suggests FDA licensing should occur 2+6 or 2+10 months from 12th December e.g. by August or December this year.  Since MDMA was granted 'Breakthrough Therapy' designation back in 2017, there's a good chance the earlier Priority review time frame may apply.  I think subsequent DEA rescheduling might take two or three more months ... so, maybe MDMA will be available for prescription use in the USA by late autumn? In the UK, the new International Recognition Procedure came into force on the 1st January.  This means that if MDMA receives FDA approval this autumn (which seems very likely), then the UK Medicines & Healthcare products Regulatory Agency (MHRA) will recognise MDMA within either a 60-day or 110-day timeline.  Since the UK has already given MDMA an approval-speeding Innovation Passport, it seems likely that MDMA licensing will follow the 60-day timeline, leading to UK licensing by the end of the year or not long after.  Lots of fingers crossed!

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