Overview

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.