A Practical Approach and Framework to Quality Management for Psychedelic Drug Development
Psychedelic Medicine January 7, 2026 Dawn Lundin
Clinical research sponsors and investigators, including those in psychedelic drug development, must design quality into studies from the start, following ICH E8 R1 and ICH E6 R3 guidelines. Identifying what is critical to quality during protocol development helps assess risks to participants and data integrity. Sponsors need systems to manage quality throughout trials, with oversight matching the risks. Quality systems should ensure compliance, adapt to shifting priorities, and grow with the company. Small start-ups face the same requirements as for any other drug or device. Despite challenges from controlled substance scheduling and psychotherapy components, adherence to regulations through a robust quality management system is required for participant safety and data reliability.