As Australia takes the lead in the prescribing of psilocybin and MDMA for mental health disorders, the European Medicines Agency has revealed some details of its regulatory agenda in this area in a letter to members of the European Parliament.
The European Medicines Agency is closely following regulatory and research developments in the area of psychedelic-assisted therapies for treating mental health conditions and is planning a multi-stakeholder workshop later this year on how to promote the use of psychedelics in addressing unmet medical needs.
The EMA is also engaging with companies working in this field in the EU, where a number of clinical trials...
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
