title: [Clinical trials with advanced therapy medicinal products].
abstract: For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challenges with advanced therapies.
authors.affiliation: Abteilung Medizinische Biotechnologie, Paul-Ehrlich-Institut, 63225, Langen. schmr@pei.de
authors.forename: M
authors.initials: M
authors.lastname: Schüssler-Lenz
authors.forename: C K
authors.initials: CK
authors.lastname: Schneider
mesh_terms: D001688:Biological Products / Q000592:standards*; D017690:Cell Transplantation / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003257:Consumer Product Safety; D015316:Genetic Therapy / Q000331:legislation & jurisprudence*; D005858:Germany; D017408:Guidelines as Topic; D006801:Humans; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence; D023822:Tissue Engineering / Q000331:legislation & jurisprudence*; D016896:Treatment Outcome
chemical_list: D001688:Biological Products