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European Medicines Agency

EMA publishes action plan to improve patient information leaflets

The European Medicines Agency (EMA) has drawn up an action plan to improve drug information following recommendations from the European Commission (EC) published in March 2017.

The action plan sets out the timescales and technicalities that will be needed to meet the objectives set out by the EC, which include improving the readability of patient information leaflets (PIL).

The EC report concluded that the language used on PILs is often too complex and the design and layout are not always user friendly. Fewer problems were identified with the summary of product characteristics (SmPC), although the EMA admitted that improvements could still be made in readability.

Other areas for improvement include generating patient input in developing and testing of PILs; promotion and exchange of best practice; and the potential use of electronic media for the SmPC and PIL.

In its plan the EMA said it would begin to explore electronic formats via a multi-stakeholder workshop, to be carried out in the third quarter of 2018, on product information and electronic media.

Stakeholders are invited to send an overview of initiatives on electronic formats for the product information that they are aware of or working on. Feedback should be sent by end of February 2018 to

The EMA said it would pilot a ‘key information’ section in both the SmPC and the PIL to enable patients to quickly find the key safety messages for a medicine.

All actions in the plan are due to be implemented within the next two years.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203985

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