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EMA expands list of excipients that must be disclosed

By Gareth Macdonald contact

- Last updated on GMT

EMA expands list of excipients that must be disclosed
The EMA has expanded the list of excipients that drug firms must declare on product labels in a bid to address safety concerns about undeclared components.

The European Medicines Agency (EMA) updated its annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use​ this week.

It said: “The main aim of this update is to take into account safety concerns which are not currently addressed in the existing annex to the guideline. It also pays specific attention to, for example, the safety of these excipients when used in children or pregnant women​.”

The agency added that: “The new safety information will help patients and healthcare professionals make more conscious decisions about the medicines they take and prescribe​.”

The update introduces five new excipients – boric acid, cyclodextrins, phosphate buffers, Sodium laurilsulfate​ and fragrances that are known allergens - and expands safety advice for 10 others.

The revisions apply to both nationally and centrally authorised products. New drugs must carry the labelling from today. Manufacturers of medicines already on the market are required to revise labelling at “the first opportunity​.”

Related topics: Regulatory & Safety

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