PAREA meeting with EMA CMO Steffen Thirstrup
In December, PAREA had a second meeting with EMA Chief Medical Officer. The Agency plans two significant activities in 2023:
i) an update of its depression guidelines which will include psychedelics
ii) publishing a paper on academic and regulatory challenges in PAT, to support their development.
EMA acknowledges that regulating psychotherapy is a challenge and one of the critical issues to address will be the standardisation of therapy. The more heterogenous the PAT delivery will be across European countries, the more concerned the regulators might be.