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EMA 'Disappointed' With Use Of Art. 58 Procedure For Non-EU Drugs

This article was originally published in SRA

Executive Summary

Would a regulatory procedure for new drugs that was used only eight times in a decade be deemed a success? Hardly. Which is why the European Medicines Agency has described as "disappointing" the pharmaceutical industry's use of the "Article 58" procedure, under which the EMA can give a positive recommendation on new medicines intended for use outside the EU1,2.

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