EMA announces first drugs to publish ePI that can be used across member states

As part of its efforts to harmonize how drug information is disseminated and managed across the EU, the European Medicines Agency (EMA) has published a drug information portal that includes information on a small list of drugs that is expected to expand in coming years.

On 8 November, EMA announced it had published a list of the first seven drugs that have electronic Product Information (ePI) that can be used across EU member states. The drugs listed are part of a pilot project and represent companies such as Sanofi, Merck Sharp & Dohme, Teva Pharmaceuticals, and Ipsen.

Generally, drug product information such as its characteristics, labeling, and packaging information are part of the documents included with the drug and are also usually available online. However, depending on the member state, the information may vary significantly.

The program aims to leverage the ease of publishing and routinely updating drug information online to help healthcare professionals and patients stay abreast of the information they need to properly use medications. The ability to publish drug information digitally should also allow regulators to update and harmonize the information across countries within its regulatory regime, according to EMA.

“These ePIs were created following the EU ePI Common Standard adopted by the European medicines regulatory network to provide a consistent structure throughout all Member States and ensure the information works across different e-health platforms,” according to an EMA statement. “This should facilitate the use of product information to meet individual needs and access requirements.”

The agency also noted that in the future, certain functions, such as automatic update notifications and online multimedia that can better present adverse reaction information, may be incorporated into the drug information and be available across EU member states in multiple languages.

EMA, the Heads of Medicine Agencies (HMA), and the European Commission (EC) are currently exploring using ePIs in a one-year pilot program under the Pharmaceutical Strategy for Europe project, which is funded through EU4Health. The ePIs already published have been reviewed by EMA or by national authorities in Denmark, the Netherlands, Spain and Sweden.

EMA noted that the drug companies who are in the pilot program have been creating and submitting their ePI information as part of their premarket application. The program currently includes 25 drugs and is slated to be completed by July 2024.

EMA announcement

EMA announces first drugs to publish ePI that can be used across member states

Related topics

Recommended content

Welcome to the new RAPS Digital Experience