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BioPharmaceutical Europe Regulation

EU Conditional Approval Should Be A Drug Development Tool, Not A Rescue Remedy

This article was originally published in SRA

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Executive Summary

Pharmaceutical companies in the EU should see conditional marketing authorization as a useful drug development planning tool, rather than as a "rescue option" to be used when they are unable to secure a full marketing authorization because they have not generated the required additional data, according to a senior European Commission official.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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