Amman, Jordan – The Jordan Food and Drug Administration (JFDA) has announced a new mandate requiring the implementation of an electronic pharmaceutical leaflet system for all registered pharmaceutical preparations. This system, which is based on XML HL7 FHIR Standards, specifically FHIR 5.0.0, will be linked to the Data Matrix two-dimensional code. The JFDA has set a strict deadline of January 17, 2025, for the re-registration of all products under these new guidelines.
This mandate represents a significant shift in the regulatory landscape, reflecting a broader global trend toward the adoption of Electronic Product Information (ePI) systems. While this change will provide patients with up-to-date pharmaceutical information, it presents considerable challenges for pharmaceutical companies. Implementing the electronic leaflet on top of the existing printed version within a six-month timeline could pose logistical difficulties, particularly in managing the increased volume of materials and ensuring compliance with the technical specifications.
For many companies, the dual requirement of maintaining conventional printed leaflets while also integrating electronic versions could strain resources. This transition phase demands meticulous attention to detail and adherence to the new standards, which could be challenging for companies with large portfolios or those less familiar with FHIR standards.
Glemser, the leader in structured content AI for regulatory content, is prepared to support pharmaceutical companies through this complex transition. With its expertise, the company can expedite the re-registration process, ensuring compliance within just five days. Glemser can also assist with the patient lens and annotation process, helping companies meet JFDA requirements efficiently.
As the industry moves toward ePI adoption, working with a trusted content authoring partner like Glemser will be crucial for staying ahead of regulatory changes. Whether you’re preparing for ePI in Jordan over the next 4-6 months or planning for a timeline closer to 6-12 months, the requirement is imminent.
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