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.
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Notes
- 1.
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials of IMPs with at least one site in the EU commencing 1 May 2004 or later.
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Acknowledgements
We would like to thank Dr. Jürgen Scherer for critical reading of the manuscript.
Disclaimer The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the Paul-Ehrlich-Institut.
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Renner, M., Anliker, B., Sanzenbacher, R., Schuele, S. (2015). Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany. In: Galli, M., Serabian, M. (eds) Regulatory Aspects of Gene Therapy and Cell Therapy Products. Advances in Experimental Medicine and Biology(), vol 871. Springer, Cham. https://doi.org/10.1007/978-3-319-18618-4_5
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