title: Swiss regulations for controlling clinical trials.
abstract: Switzerland has recently issued regulations designed to control all trials with drugs in human subjects, namely the 'Regolamento dell'Ufficio Intercantonale per il controllo dei medicamenti in fase di studio clinico' (Intercantonal Regulations Controlling Drugs used in Clinical Trials), which have been operating since 1st January 1995. These new regulations are generally consistent with other international regulations and have introduced the concept of good clinical practice (GCP) into Switzerland. There are other regulations in Switzerland, such as Federal regulations on immunobiological products, special rules governing the administration of radiolabelled drugs to humans, drugs of abuse and medical devices. Any gap in the central regulations must be filled by cantonal regulations, where they exist. This is a comprehensive review of the regulations governing clinical trials in Switzerland, with special attention being devoted to trials with therapeutic compounds and to compatibility between Swiss and international procedures.
authors.affiliation: Dipartimento Dello Opere Sociali, Ufficio del farmacista cantonale, Mendrisio, Switzerland.
authors.forename: G M
authors.initials: GM
authors.lastname: Zanini
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000639:trends; D006801:Humans; D010601:Pharmacology, Clinical / Q000331:legislation & jurisprudence* / Q000639:trends; D013557:Switzerland