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So Far, So Good On EMA's PRIME, With One Caveat

This article was originally published in SRA

Executive Summary

All 18 applications1 submitted for entry into the European Medicines Agency's new PRIME (priority medicines) scheme in the month after its launch were 'in scope' and of a quality that meant the assessments could be done without the EMA having to go back to any of the applicants. 'Either you are very good or our templates are very good or both,' joked the EMA official in charge of the department responsible for developing the scheme.

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