Abstract
Although regulatory standards and procedures in Europe have improved following the establishment of the European Medicines Agency (EMEA), the number of major issues with marketing authorization applications for biotechnological products remains high. For example, the pivotal clinical trials of some late-stage failures have been found not to meet the regulatory guidelines of the European Union, and regulators are increasingly concerned that attempts to accelerate the process of biotechnological product development leads to the neglect of important issues. Based on the scientific decisions of the EMEA's major scientific committees, in this article we identify and discuss frequent concerns, and suggest approaches that might enable developers of biotechnological products to avoid these common pitfalls.
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Acknowledgements
We are grateful to J. Löwer, the President of the PEI and Acting President of the BfArM (German Federal Institute for Drugs and Medical Devices); M. Haase (long-standing previous member of the CHMP); J. Müller-Berghaus (PEI, SAWP); and P. Volkers (PEI, Efficacy Working Party) for support and their helpful and encouraging discussion on the manuscript.
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Schneider, C., Schäffner-Dallmann, G. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe. Nat Rev Drug Discov 7, 893–899 (2008). https://doi.org/10.1038/nrd2728
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DOI: https://doi.org/10.1038/nrd2728
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