title: Providing Quality Therapeutics in Switzerland: Role of the Stakeholders and Recent Incentives for Further Improvements.
abstract: Quality therapeutics play an important role in Switzerland's health care and economy. Switzerland holds a key position in the world of research and development, as well as in drug production. Recently, new emphasis has been placed on promoting clinical research and maintaining Switzerland's position as a center of excellence in the field. Recent revisions to the law regarding medical trials in human research allow for better allocation of regulatory resources and simplified procedures for drugs already authorized in Switzerland. The country has its own regulatory agency, the Swiss Agency for Therapeutic Products (Swissmedic), which is a public institution of the Swiss government. Swissmedic is responsible for ensuring safety in medicines, particularly regarding authorizations and market surveillance in the sector of medicinal products and medical devices. Although the centralized authorization procedure of the European Union for medicines does not apply to Switzerland, there are mutual recognition mechanisms between the Swiss medicine regulatory authority and the European Medicines Agency. Swissmedic is also in charge of postmarketing safety and oversees the national pharmacovigilance center, which collaborates closely with the World Health Organization center in Uppsala. In addition, university hospital-based clinical pharmacologists, who are involved in basic science and clinical research, regulatory affairs, ethics committees, and pharmacovigilance, promote quality therapeutics. This article discusses the role of the various stakeholders and the recent efforts made to provide a better allocation of resources aimed at further improving quality therapeutics in Switzerland.
authors.affiliation: Psychopharmacology Unit, Division of Clinical Pharmacology and Toxicology, University Hospital of Geneva, Geneva, Switzerland. Electronic address: marie.besson@hcuge.ch.
authors.forename: Marie
authors.initials: M
authors.lastname: Besson
authors.affiliation: Division of Clinical Pharmacology and Toxicology, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Caroline
authors.initials: C
authors.lastname: Samer
authors.affiliation: Division of Clinical Pharmacology and Toxicology, University Hospital of Geneva, Geneva, Switzerland; Clinical Research Center, University Hospital and Faculty of Medicine of Geneva, Geneva, Switzerland.
authors.forename: Victoria
authors.initials: V
authors.lastname: Rollason
authors.affiliation: Division of Clinical Pharmacology and Toxicology, University Hospital of Geneva, Geneva, Switzerland; Medical Direction, University Hospital of Geneva, Geneva, Switzerland.
authors.forename: Pierre
authors.initials: P
authors.lastname: Dayer
authors.affiliation: Division of Clinical Pharmacology and Toxicology, University Hospital of Geneva, Geneva, Switzerland; Clinical Research Center, University Hospital and Faculty of Medicine of Geneva, Geneva, Switzerland.
authors.forename: Jules
authors.initials: J
authors.lastname: Desmeules
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000458:organization & administration; D055808:Drug Discovery / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D009042:Motivation; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence; D058996:Quality Improvement; D013557:Switzerland
keywords: Quality; Stakeholders; Switzerland; Therapeutics