EMA Updates Guidelines on Excipients in Labeling

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Europe updates the guideline on excipients information in labeling and packaging.

On October 9, 2017, the European Medicines Agency (EMA) announced that the annex to the guideline on excipients in labeling and packaging of drug products has been updated to include all excipients that must be listed in the labeling and packaging leaflets of drugs and their safety warnings.

The guideline was updated to take into consideration safety concerns not currently addressed in the existing annex, with specific attention to excipients that may affect children or pregnant women. Five new excipients are included, and 10 have been updated with new safety warnings.


Source: EMA