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Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland.
Adv Exp Med Biol. 2015; 871:131-45.AE

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+Show Affiliations

Inspectorates, Section Transplants, Swissmedic, Swiss Agency for Therapeutic Products, Hallerstrasse 7, Berne, 3000, Switzerland. andreas.marti@swissmedic.ch.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374216

Citation

Marti, Andreas. "Requirements for Clinical Trials With Gene Therapy and Transplant Products in Switzerland." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 131-45.
Marti A. Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland. Adv Exp Med Biol. 2015;871:131-45.
Marti, A. (2015). Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland. Advances in Experimental Medicine and Biology, 871, 131-45. https://doi.org/10.1007/978-3-319-18618-4_7
Marti A. Requirements for Clinical Trials With Gene Therapy and Transplant Products in Switzerland. Adv Exp Med Biol. 2015;871:131-45. PubMed PMID: 26374216.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland. A1 - Marti,Andreas, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Clinical considerations KW - Clinical trial KW - GMO KW - Gene therapy KW - Marketing authorization KW - Nonclinical considerations KW - Quality considerations KW - Regulatory authority KW - Scientific advice KW - Swissmedic KW - Switzerland KW - Transplant product SP - 131 EP - 45 JF - Advances in experimental medicine and biology JO - Adv Exp Med Biol VL - 871 N2 - 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. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374216/Requirements_for_Clinical_Trials_with_Gene_Therapy_and_Transplant_Products_in_Switzerland_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_7 DB - PRIME DP - Unbound Medicine ER -