EMA Adds New Excipients to Labeling Requirements

The European Medicines Agency (EMA) on Monday updated its annex to the European Commission's guideline on excipient labeling, adding five new excipients and expanding the safety warnings required for 10 others.

Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are thought to be inactive, though some can cause reactions in certain circumstances. For instance, lactose is commonly used as a filler in drug tablets, but can cause reactions in patients who are lactose intolerant.

The document, which lists the excipients that are "known to have a recognized action or effect" that must be declared in a medicine's label and package leaflet, is being updated for the first time since its publication in 2003.

The update also comes as the European Commission considers revisions to its excipient labeling guideline following a public consultation that closed in May.

The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and fragrances containing allergens. The annex includes an appendix listing 26 specific fragrance allergens such as cinnamal and oak moss that are required to be included in labeling.

As for the new safety information, EMA says the revised annex "pays specific attention to…the safety of these excipients when used in children or pregnant women."  For example, the annex includes new safety information that must be listed in the package leaflet for drugs containing benzyl alcohol advising women who are pregnant or breast feeding to consult with their doctor or pharmacist before taking the drug.

EMA says the revised annex goes into effect immediately for all centrally and nationally authorized medicines, and current marketing authorization holders are instructed to update their product labeling at the first opportunity. For products with no upcoming regulatory submissions, EMA says sponsors should submit a type IB variation detailing any labeling changes within the next three years.

EMA