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Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.
Adv Exp Med Biol. 2015; 871:87-101.AE

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+Show Affiliations

Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straβe 51-59, Langen, 63225, Germany. matthias.renner@pei.de.Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straβe 51-59, Langen, 63225, Germany. Brigitte.Anliker@pei.de.Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straβe 51-59, Langen, 63225, Germany. Ralf.Sanzenbacher@pei.de.Division of Medical Biotechnology, Paul-Ehrlich-Institut-Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straβe 51-59, Langen, 63225, Germany. Silke.Schuele@pei.de.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374214

Citation

Renner, Matthias, et al. "Regulation of Clinical Trials With Advanced Therapy Medicinal Products in Germany." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 87-101.
Renner M, Anliker B, Sanzenbacher R, et al. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany. Adv Exp Med Biol. 2015;871:87-101.
Renner, M., Anliker, B., Sanzenbacher, R., & Schuele, S. (2015). Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany. Advances in Experimental Medicine and Biology, 871, 87-101. https://doi.org/10.1007/978-3-319-18618-4_5
Renner M, et al. Regulation of Clinical Trials With Advanced Therapy Medicinal Products in Germany. Adv Exp Med Biol. 2015;871:87-101. PubMed PMID: 26374214.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany. AU - Renner,Matthias, AU - Anliker,Brigitte, AU - Sanzenbacher,Ralf, AU - Schuele,Silke, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - ATMP KW - CBMP KW - Clinical trials KW - GTMP KW - Regulatory SP - 87 EP - 101 JF - Advances in experimental medicine and biology JO - Adv Exp Med Biol VL - 871 N2 - 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. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374214/Regulation_of_Clinical_Trials_with_Advanced_Therapy_Medicinal_Products_in_Germany_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_5 DB - PRIME DP - Unbound Medicine ER -