title: [Safety monitoring of cell-based medicinal products (CBMPs)].
abstract: Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.
authors.affiliation: Abteilung Sicherheit von Arzneimitteln und Medizinprodukten, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland. markus.funk@pei.de.
authors.forename: Markus B
authors.initials: MB
authors.lastname: Funk
authors.affiliation: Abteilung Sicherheit von Arzneimitteln und Medizinprodukten, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
authors.forename: Marion
authors.initials: M
authors.lastname: Frech
authors.affiliation: Abteilung Sicherheit von Arzneimitteln und Medizinprodukten, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
authors.forename: Robert
authors.initials: R
authors.lastname: Spranger
authors.affiliation: Abteilung Sicherheit von Arzneimitteln und Medizinprodukten, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Keller-Stanislawski
mesh_terms: D001688:Biological Products / Q000592:standards*; D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D005858:Germany; D006801:Humans; D007880:Legislation, Drug / Q000592:standards*; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D011786:Quality Control; D058996:Quality Improvement / Q000331:legislation & jurisprudence / Q000592:standards
chemical_list: D001688:Biological Products
keywords: CBMP/ATMP; Drug approval process; Drug legislation; Post authorisation safety study; Safety