title: [Report from the Committee for Advanced Therapies (CAT). Pitfalls on the way from concept to medical treatment with advanced therapy medicinal products].
abstract: Advanced therapy medicinal products (ATMP) are highly innovative and complex medicines. They comprise gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products (TEP). With the European Regulation on ATMP that came into force in 2008, a consolidated regulatory framework was created, where the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) plays a central role. This article discusses pitfalls and challenges that the CAT has experienced in its discussions of various procedures. Often ATMPs are developed by small and medium-sized enterprises (SME) which also face nonscientific challenges. The CAT wishes to meet these challenges on a scientific and regulatory level during its 2010-2015 work program.
authors.affiliation: Referat L1, Leitungsassistenz, Paul-Ehrlich-Institut (PEI), Langen, Deutschland.
authors.forename: M
authors.initials: M
authors.lastname: Reiss
authors.forename: I C
authors.initials: IC
authors.lastname: Büttel
authors.forename: C K
authors.initials: CK
authors.lastname: Schneider
mesh_terms: D026683:Advisory Committees; D001688:Biological Products / Q000627:therapeutic use*; D001709:Biotechnology; D003257:Consumer Product Safety; D005062:European Union; D015316:Genetic Therapy; D006801:Humans; D018570:Risk Assessment; D033581:Stem Cell Transplantation; D035703:Therapies, Investigational; D023822:Tissue Engineering
chemical_list: D001688:Biological Products