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SMEs Are Keen Users Of EMA Regulatory Support, But Say They Want More

This article was originally published in SRA

Executive Summary

In the 10 years since the European Medicines Agency set up a dedicated office to offer advice to small and medium-sized companies in 2006, SMEs have filed 119 marketing authorization applications and have been assiduous users of the EMA's scientific advice process, especially for biomarker qualification and parallel advice with health technology assessment (HTA) bodies.

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