European Commission Calls on EMA to Clarify Package Leaflets, Product Summaries

April 5, 2017

The European Commission is recommending that the European Medicines Agency require clearer information on drug package leaflets and summaries of product characteristics.

In a new report, the Commission recommends ways to make the information for healthcare workers and consumers easier to understand. The text on package leaflets is often too complex and not user-friendly, especially for the elderly and patients with lower literacy skills, the Commission says.

EMA guidelines for package leaflets should include design principles, which would also help improve industry compliance with legibility requirements for package leaflets.

The report calls on the EMA to revise its guidelines, particularly as they relate to readability. The Commission also recommends improved user-testing of translations to ensure the meaning remains clear.

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