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In ever-evolving landscape of pharmaceutical regulations, ensuring the accurate and efficient exchange of medicinal product information is paramount. The Identification of Medicinal Products (IDMP) standard has emerged as a framework to streamline data management and reporting across the industry.
Implemented by the European Medicines Agency (EMA) through the Substance, Product, Organisation, and Referential (SPOR) program, IDMP establishes a comprehensive structure for collecting, managing, and sharing medicinal product data. SPOR will eventually facilitate a smooth flow of data among various stakeholders, supporting product safety, traceability, and efficient monitoring of products throughout their lifecycle.
EMA’s Product Management Services (PMS) system will eventually require IDMP data for medicinal products to be submitted using the Fast Healthcare Interoperability Resources (FHIR®) message format, which can provide a seamless exchange of IDMP data between the industry and regulators.
However, the documentation journey from various sources to IDMP data and, ultimately, to the FHIR format is no simple task. For this process, one should consider transforming the data into an up-to-date FHIR format (technology that can map between IDMP data and the FHIR messaging specification) and deploying an API to exchange the data.
Read Also: Importance of IDMP Сompliance
This involves adhering to regulatory guidelines and ensuring compatibility with the specific FHIR standards for medicinal product information.
FHIR: Enabling Streamlined Medicinal Product Information Management
FHIR, a specification developed and maintained by Health Level Seven® International (HL7®), offers a modern framework for seamless health data exchange. For managing medicinal product information, FHIR structured resources such as “Medication” or “Substance” align perfectly with the complexities of IDMP data.
Empowering Pharmaceutical Companies: The Strategic Advantages of ePI Delivery
The conversion of IDMP data into the FHIR format is more than a compliance measure towards EMA regulations; it also paves the way for effective electronic product information (ePI) delivery for pharmaceutical companies.
Product information for medicines is essential, providing regulated data to guide healthcare professionals and ensure safe consumer use. By creating and sharing this information electronically via FHIR, the industry can benefit from a unified global approach that offers multiple advantages.
Recently, Vulcan HL7 FHIR Accelerator and Gravitate Health announced the publication of a FHIR implementation guide. This will further solidify FHIR’s place as the emerging standard practice in the industry, reinforcing the global move toward unified and effective health data exchange.
An End-to-End Solution: Documentation to IDMP Data to FHIR Format
Iperion (a Deloitte business providing consultancy and managed services in regulatory information management for life sciences) and the Kodjin FHIR Server (a scalable FHIR server developed by Edenlab to support high-load projects) collaborated to develop an end-to-end solution that simplifies the intricate process of transforming IDMP data into the FHIR format. This comprehensive approach eliminates the burden of manual data conversion. It focuses on the FHIR aspect, which is important for future regulatory PMS submissions and sets a basis for advancements such as Electronic Product Information (ePI).
How does it work?
- AI-Powered Data Collection: Through Iperion’s AI tool, DocQMiner, we collect and remediate IDMP data from various sources.
- Transformation to FHIR Format: The Kodjin FHIR Server can be employed and designed for transforming structured IDMP data into the FHIR format if required (depending on where the remediated IDMP data is stored).
- Validation and Transmission: The structured data undergoes rigorous validation and is made query-ready, enabling seamless transmission through our server’s advanced capabilities and providing the necessary parameters and RESTful API operations. Modifications to this server can be performed at any time to align with potential technical specifications shared by the industry.
With a blend of innovation, technology, and expertise, our solution is paving the way for a more efficient and responsive pharmaceutical industry, specially for data interoperability in pharmaceutical field.
Join Our Exclusive Webinar on October 18, 2023!
The regulatory landscape for pharmaceuticals is rapidly transforming, and the alignment between IDMP Data and FHIR is at the core of this change. Explore our efficient, compliant, and forward-thinking solution to this complex challenge in our upcoming webinar!
Why Attend?
- Understanding the New Landscape: The IDMP framework, SPOR program, and the FHIR messaging format are redefining the exchange of medicinal product information.
- Comprehensive Solutions Unveiled: Discover how an end-to-end solution can advance data remediation, enable transformations to FHIR, and create future advancements like ePI.
- Expert Insights: Engage with leading experts from Iperion and Edenlab and get your questions answered.
Don’t miss the opportunity to gain insights into the transformation of pharmaceutical data management. Sign up here!
