A Common European EPI Standard for Medicines is Adopted by EMRN
A single electronic Product Information (EPI) standard for human medications has been established by the European Medicines Regulatory Network (EMRN). The European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European Commission collaborated on the common ePI standard as one of their major projects (EC). In September 2021, the EU Network Data Board approved the EU ePI common standard, and the announcement was made on February 22, 2022.
The package leaflet for patients and the Summary of Product Characteristics (SmPC) for healthcare workers are both included in the PI. It is a vital feature of any pharmaceutical marketed in the EU, providing suggested usage and prescription information. Details such as the SmPC, which is an electronic counterpart of the PI, are included in the ePI. On the web, on e-platforms, and in print, you can find package leaflets and labels.
What is the Common Standard for ePI?
The technical aspects of the ePI are generally agreed upon by the respective Regulatory Authority and stakeholders (sponsors, medication makers, etc.). The most recent common standard assures that electronic information on human pharmaceuticals is consistent. On electronic portals, authorised information for a drug is updated in a semi-structured fashion. Fast Healthcare Interoperability Resources (FHIR), a technical standard for describing data formats and elements, provides the foundation for the ePI common standard. FHIR stands for Fast Healthcare Interoperability Resources. It is an application programming interface for transferring electronic health records.
The following are included in the common ePI standard:
• The ePI Active Pharmaceutical Ingredient (API) specification and service list.
• A FHIR template based on the Human Medicines Quality Review of Documents (QRD) template.
The Advantages of Using the ePI Common Standard
• Improved and timely distribution of information to assist patients, healthcare professionals, and other end-users inside the EU through a unified electronic information system for medications.
• A user-friendly electronic system that can be accessed from the convenience of their own homes.
• All pharmaceutical information is updated and made available in real time.
Automatic update notifications, audio and video content to complement the PI, and online adverse reaction reporting systems are all planned by the EMA in the future.
The ePI Common Standard is being implemented.
The EMA is testing the ePI in regulatory procedures in a pilot study. The EU4Health Programme, which runs from 2021 to 2027, is funding the initiative.
Adopting a new technical update for human drugs and associated APIs can be fairly difficult. Contact a regulatory expert like Freyr if you need help adopting the common ePI standard for EU compliance.
Category: Pharmaceuticals, Regulatory Labeling, Health Authority Updates
Key Words: Pharmaceuticals, Consumer Healthcare, Regulatory Labeling, Health Authority Updates EMRN, EMA, Regulatory Affairs, EU, Labeling Standards, Harmonization
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