FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Considers Electronic Product Information Standard for Drugs

Feb. 7, 2019
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The European Medicines Agency began a six-month public consultation for draft principles on a common EU standard for human drug electronic product information.

The common ePI standard “will reflect the reality of interlinked medicines’ regulatory systems” and meet the expectations of patients and healthcare professionals who travel and work in several EU countries,” according to the draft.

The EMA considers ePI a public health priority as it will expand the dissemination of up-to-date, regulator-approved product information for all drugs in the EU. The information will provide the latest safety, efficacy and conditions-of-use information, and improve delivery of information and informed decision-making.

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