title: Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland.
abstract: This chapter aims to describe and summarize the regulation of gene and cell therapy products in Switzerland and its legal basis. Product types are briefly described, as are Swiss-specific terminologies such as the term "transplant product," which means products manufactured from cells, tissues, or even whole organs. Although some parts of this chapter may show a guideline character, they are not legally binding, but represent the current thinking of Swissmedic, the Swiss Agency for Therapeutic Products. As so far the experience with marketing approval of gene therapy and cell therapy products in Switzerland is limited, this chapter focuses on the regulation of clinical trials conducted with these products. Quality, nonclinical, and clinical aspects are summarized separately for gene therapy products and transplant products.
authors.affiliation: Inspectorates, Section Transplants, Swissmedic, Swiss Agency for Therapeutic Products, Hallerstrasse 7, Berne, 3000, Switzerland. andreas.marti@swissmedic.ch.
authors.forename: Andreas
authors.initials: A
authors.lastname: Marti
mesh_terms: D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000941:ethics* / Q000379:methods; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D015316:Genetic Therapy / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence; D040541:Marketing / Q000331:legislation & jurisprudence*; D061214:Patient Safety / Q000331:legislation & jurisprudence; D017410:Practice Guidelines as Topic; D011786:Quality Control; D012107:Research Design; D013557:Switzerland; D016378:Tissue Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence*; D057170:Translational Research, Biomedical / Q000941:ethics / Q000331:legislation & jurisprudence*
keywords: Clinical considerations; Clinical trial; GMO; Gene therapy; Marketing authorization; Nonclinical considerations; Quality considerations; Regulatory authority; Scientific advice; Swissmedic; Switzerland; Transplant product