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    EMA preps for EU common standard on electronic product information

    The European Medicines Agency (EMA) this week launched a stakeholder consultation on a draft EU common standard for electronic product information (ePI) for human medicines.   The common standard would provide a semi-structured template for ePI incorporating the authorized, statutory product information for medicines, including the summary of product characteristics (SmPC), labeling and package leaflet. EMA says that ePI will be better suited “for electronic handling a...
  • Regulatory NewsRegulatory News

    EU Begins Transition to Electronic Product Information for Medicines

    The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) on Thursday launched a six-month public consultation on the draft key principles that will form the basis for creating electronic product information (ePI) for medicines in the EU. Derived from conversations with EMA, EC, HMA and various stakeholders, the draft key principles explain how ePI, which includes the package leaflet for patients and the summary of product...