SWISS REGULATIONS FOR CONTROLLING CLINICAL-TRIALS

Switzerland has recently issued regulations designed to control all tr ials with drugs in human subjects, namely the 'Regolamento dell'Uffici o Intercantonale per il controllo dei medicamenti in fase di studio cl inico' (Intercantonal Regulations Controlling Drugs used in Clinical T rials), which have been operating since 1st January 1995. These new re gulations are generally consistent with other international regulation s and have introduced the concept of good clinical practice (GCP) into Switzerland. There are other regulations in Switzerland, such as Fede ral regulations on immunobiological products, special rules governing the administration of radiolabelled drugs to humans, drugs of abuse an d medical devices. Any gap in the central regulations must be filled b y cantonal regulations, where they exist. This is a comprehensive revi ew of the regulations governing clinical trials in Switzerland, with s pecial attention being devoted to trials with therapeutic compounds an d to compatibility between Swiss and international procedures. (C) 199 8 The Italian Pharmacological Society.