Published May 5, 2022

European regulators on 22 February 2022 announced the adoption of a common electronic product information (ePI) standard for human medicines that can be accessed by users and healthcare providers.

According to the European Medicines Agency (EMA), the “EU ePI Common Standard” will “support the provision of harmonized electronic information on medicines within the EU and is a step towards improved delivery of information for patients, consumers, and healthcare professionals to aid their informed decision-making.”

The Common Standard was one of the key deliverables of an ePI project run by the European Medicines Agency (EMA), national competent authorities (NCAs) and the European Commission (EC) in 2021. A follow-on pilot project supported by the EU’s funding program EU4Health will now focus on developing tools and guidance to pilot the use of ePI prior to implementation.

For more information, please visit the EMA website:  https://www.ema.europa.eu/en/news/european-medicines-regulatory-network-adopts-eu-common-standard-electronic-product-information