title: Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.
abstract: In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.
authors.affiliation: Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straße 51-59, Langen, 63225, Germany. matthias.renner@pei.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Renner
authors.affiliation: Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straße 51-59, Langen, 63225, Germany. Brigitte.Anliker@pei.de.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Anliker
authors.affiliation: Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straße 51-59, Langen, 63225, Germany. Ralf.Sanzenbacher@pei.de.
authors.forename: Ralf
authors.initials: R
authors.lastname: Sanzenbacher
authors.affiliation: Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straße 51-59, Langen, 63225, Germany. Silke.Schuele@pei.de.
authors.forename: Silke
authors.initials: S
authors.lastname: Schuele
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*; D005062:European Union; D015316:Genetic Therapy / Q000941:ethics / Q000331:legislation & jurisprudence*; D005858:Germany; 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; D057170:Translational Research, Biomedical / Q000941:ethics / Q000331:legislation & jurisprudence*
keywords: ATMP; CBMP; Clinical trials; GTMP; Regulatory