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European Directorate for the Quality of Medicines (EDQM)

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Approval of regulatory starting materials

27 October 2020 | By

There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…