8 August 2023

EMA/HMA ePI Pilot Project


EMA and its partners within the European medicines regulatory network are taking a significant step forward by embracing electronic product information (ePI) for human medicines within the EU. This ePI initiative refers to providing an electronic version of PI, not pertaining to any changes in PI content or current legislation applicable to the PI. By transitioning from traditional paper-based product information to electronic formats, the EMA aims to enhance accessibility, searchability, and multilingual capabilities while integrating with electronic healthcare systems.

In a one-year pilot project commencing in July 2023, the EMA, along with certain EU national competent authorities, will test the implementation of ePI for regulatory procedures. The pilot project encompasses both centralised and national regulatory procedures. Participating countries include Denmark, the Netherlands, Spain, and Sweden.

Billev Pharma East is proud, Katja Pečjak, acts as an Industry Subject Matter Expert for the EMA/HMA ePI pilot project. With her expertise, Billev Pharma East is contributing valuable insights and knowledge to the project, supporting the successful implementation of ePI in the EU.

The pilot project will utilize an ePI authoring tool within the Product Lifecycle Management Portal to generate ePI for regulatory procedures in real time. This tool will enable efficient creation and management of ePI. Guidelines and training materials are already available to support the ePI pilot participants in assessing and navigating through the platform. Once the ePI has been approved by regulators, it will be made publicly accessible.

The adoption of ePI for human medicines offers numerous advantages. By digitizing product information (summary of product characteristics, package leaflet, and labelling), the accessibility of crucial details will be greatly improved. Regulators and the pharmaceutical industry will be able to use ePI to create efficiencies in routine management of the PI during regulatory procedures and to facilitate analysis of information contained in the PI. Healthcare professionals and patients will benefit from more convenient access to accurate and up-to-date information, facilitating informed decision-making. Furthermore, ePI enables integration with electronic healthcare systems, streamlining workflows and enhancing efficiency within the healthcare sector.

A medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about their medicine and its safe use. It is envisaged that, eventually, ePI format will be used for the PI of all human medicines authorized in the EU through EMA and NCAs from the point of submission and throughout the evaluation process. However, timelines and processes for implementation will be flexible and amenable to the available resources and priorities at national level. The development of ePI is intended to improve access to up-to-date product information on medicines when and where it is needed and will be available to healthcare professionals, patients, and the public in the EU.