Clinical studies and registration procedures for psychiatric drugs - a pharmaceutical medicine perspective

The article intends to broach the issue of clinical development and formal registration for psychiatric drugs which are also used in general medicine. Due to the historical shift from national to European registration procedures in the EU, new compounds for major psychiatric disorders (e. g., Major Depression) are centrally evaluated by the EMEA (European Agency for the Evaluation of Medicinal Products; North America: FDA). Clinical development programs by the pharmaceutical industry follow the CHMP (Committee for Medicinal Products for Human Use) guidelines (Note for guidance on clinical investigation of medicinal products), and refer mainly to syndromal diagnostic criteria of major psychiatric disorders due to ICD and DSM. Furthermore, they refer more or less to the proof of efficacy and safety in acute disease states. Instead, psychopharmacotherapy in the field of psychiatry and related areas is frequently driven by different and more symptomatic indications. Furthermore the long-term outcomes and other specific aspects of pharmacotherapy (e. g., working and driving ability) are important for patients and physicians. Thus, there is need to consider those issues also with regard to oft-label-use and the increasing request (by national agencies like NICE, IQWiG) for cost-effectiveness data from naturalistic studies (phase IV research).