Serotonergic psychedelics such as psilocybin, lysergic acid di­ ethylamide (LSD), or dimethyltryptamine (DMT), as well as psychoactive drugs that trigger phenomenologically- related experiences like 3,4-methylenedioxymethamphetamine (MDMA) and ketamine, belong to the most promising treat­ment approaches in contemporary psychiatry. Psychedelic assisted psychotherapy is not only a new treatment paradigm In psychopharmacology, but it also requires a redefinition of psychotherapeutic processes and the contextualization of psychopharmacological interventions within a new treatment infrastructure. Crucial for future practice and research in the field are (1) informed patient referral and co-treatment prac­tices, (2) screening (e. g., choosing the right patients for these therapies), (3) the dosing preparation sessions, (4) the assisted dosing sessions as well as after-care procedures such as (5) psychological integration and (6) supporting the development of structured patient communities. Definition of future treat­ment delivery infrastructures and requirements for therapist training are further challenges for research and practice. Fi­nally, the implementation of psychedelic-assisted psychother­apy in routine mental health care must be embedded into public communication about the potential and risks of these innovative therapeutic approaches. This paper provides a syn­opsis of challenges for practitioners, researchers, and regula­tors to be addressed in the approval processes of psychedelics.