In this week’s PharmaTimes article, Professor Allan Young (Institute of Psychiatry, King’s College London) explains why the unique service offered by ECHO (European Consortium for Observational Studies on Mental Health Products) has such an important role to play in bringing new mental health products to market in Europe.
While many new drugs in the mental health sector are first launched in the US, they must undergo post-authorisation safety studies (PASS) and other observational studies in Europe as a condition of approval by the European Medicines Agency (EMA) and other medicines regulators. ECHO is well-placed to conduct these studies, with its pharmacoepidemiological expertise, in-depth understanding of pharmacovigilance regulations, and understanding of healthcare and access to research networks in at least six European countries.
ECHO is a unique combination of the expertise of the DSRU with the experience and networks of six consultant psychiatrists from across Europe. The DSRU has conducted PASS studies on over a dozen mental health products in both primary and specialist care, and also offers risk minimisation studies, drug utilisation studies, registries and other observational study methods.