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EMA consults on definition of starting materials for specific biological medicines

This article was originally published in SRA

Executive Summary

The European Medicines Agency has published a draft reflection paper to help manufacturers preparing marketing authorisation dossiers understand what would constitute a "starting material" in the case of specific groups of biological medicines1. The paper, which clarifies the definition of starting materials for such products, also addresses the extent to which any variability in the early manufacturing steps for the biologics would be acceptable.

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