THE CLINICAL PHARMACOLOGIST IN DRUG REGULATION - A EUROPEAN PERSPECTIVE

1 The clinical pharmacologist in drug regulation has many roles to pla y. These include responsibilities for the premarketing assessment of a new product's efficacy and safety, for scrutiny of the summary of Pro duct Characteristics, and for monitoring its performance after marketi ng. Furthermore, the clinical pharmacologist has a subsidiary responsi bility in examining the results of preclinical pharmacological and tox icological studies. 2 Clinical pharmacologists in regulatory authoriti es have one further, and crucial, responsibility-humility. From their training and experience they will (or should) know of their own scient ific limitations and of the necessity for seeking help and advice from other disciplines.