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… (More)
DOI: 10.1007/978-3-319-18618-4_5

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Cite this paper

@article{Renner2015RegulationOC, title={Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.}, author={Matthias Renner and Brigitte Anliker and Ralf Sanzenbacher and Silke Schuele}, journal={Advances in experimental medicine and biology}, year={2015}, volume={871}, pages={87-101} }