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EMA Review Of Non-EU Drugs To Be Made More Useful For African Regulators

Executive Summary

The European Medicines Agency is looking into how it can better promote the Article 58 procedure under which it evaluates the quality, safety and efficacy of medicines or vaccines intended for use outside the EU. The procedure has been underutilized by industry to date and the EMA wants to encourage its use, especially for drugs to be used in Sub-Saharan Africa.

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