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Ensuring A Bright Future For The EU Orphan Medicines Regime

This article was originally published in SRA

Executive Summary

Since the EU orphan medicines regime was established in April 2000, it has resulted in around 1,600 orphan medicine designations and more than 120 marketing authorizations for orphan medicines. Now, though, some of the key principles governing the criteria and procedure for orphan designation are being reviewed, and it is important that all stakeholders contribute to the ongoing consultation to help ensure a robust regime for the future, says Peter Bogaert.

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