European Medicines Regulatory Network Adopts EU Common Standard for Electric Product Information

News
Article

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

The European Medicines Regulatory Network has adopted a Common Standard for the electric product information (ePI) on medicines in the EU on Feb. 22, 2022. 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.

The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. Every single medicine authorized in the EU includes these documents that help explain how it should be used and prescribed.

The adoption of the Common Standard will allow for the spread of unbiased, up-to-date information on all medicines available to patients in the EU. The EU ePI Common Standard will provide the ability to harmonize electronic information on medicines within the EU and improve the delivery of information for patients, consumers, and healthcare professionals for better decision making. The ePI can be updated immediately as new information becomes available and can be personalized to be more easily accessible to users with diverse abilities.

Source: EMA

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes