Some advancements in the system bring along potential opportunities for significant improvements in the processes. On the same line, to quickly identify the substances and products involved in the adverse events, the EMA amending its earlier regulations (XEVMPD format) is in the process of implementing the ISO IDMP (Identification of Medicinal Products) standards.
Leading to start the implementation as per the international requirements and the EU principles, the EMA has established an ISO IDMP Task Force with a focus to give advice on the planning, development, and maintenance of the ISO IDMP standards in the EU region. The main focus of the implementation is to improve the global monitoring of patient safety by providing universal ID for drugs which can be referenced in ICSR (Individual Case Safety Reports). Therefore to enable the European regulators track, monitor, suspect, and report the adverse events while marketing their products in the Europe.
Aligning with the ISO IDMP standards, the biggest challenge organizations could face is to capture the humongous amount of Regulatory data (manufacturing, quality, safety, and clinical) pertaining to each medicinal/pharmaceutical product. Enroute, data consolidation and record maintenance may increase organization’s compliance costs and may involve significant risks of inconsistency between submissions and marketed products.
Being a specialist provider of Regulatory Consulting, Operations & Technology Services, Freyr simplifies data consolidation and provides efficient and seamless ISO IDMP submissions services. Integrated with Regulatory Master Data Management System (MDM), Freyr IDMP provides a single source of truth for all the medicinal products enabling clients to effectively manage the product data. Freyr’s Enterprise Regulatory Information Management Solution and strategic IDMP Consulting and Implementation Services enable companies to effectively gain IDMP compliance readiness within the required timelines.
- Data level status reports and analytics in terms of availability, accuracy, and integrity
- Data Consideration Factors:
Consulting & Compliance Services
- Provide data management strategy and implementation approach
- Perform IDMP readiness, gap analysis and future state recommendations
- No need for any technology solution (hosted or on-premise)
- Cost-effective ‘Per- Market Authorization’ or ‘Per-Product’ pricing model
- Structured strategy for implementing IDMP and create IDMP baseline
- Support for Source identification, data gap analysis and mapping for IDMP
- Robust workforce with commitment for IDMP compliance
- Proven ability to fulfil client requirements with ensured quality
- Dedicated team involving CMC, PV, Artworks etc. to identify the change management triggers and maintenance of IDMP data
Freyr IDMP The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Once implementation has been fully completed, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these standards.
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