ZS asset on IDMP enabled product data management
What is IDMP?
The Identification of Medicinal Products (IDMP) is a set of standards created by the International Organization for Standardization (ISO) that mandates a unified data structure and vocabulary for medicinal product data submissions. This standardization aims to improve data sharing, automation, and efficiency across regulatory, supply chain, and clinical functions within an organization, ultimately enhancing patient outcomes. These standards also help to ensure wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and unambiguous communication across jurisdictions.
What challenges are targeted by IDMP?
Life sciences-based companies must navigate a complex global regulatory environment and maintain a comprehensive view of regulatory standards of products data to ensure compliance. Without this, they face challenges such as data silos, inconsistent data formatting, unable to identify unique products, incorrect data entry, frequent design changes, manufacturing issues, traceability problems etc. IDMP standards affect various pharmaceutical functions, including regulatory, clinical, manufacturing, and supply chain. Companies that implement holistic compliance reporting and robust master data management solutions can overcome data challenges and process inefficiencies.
ZS Asset on IDMP
ZS has developed solutions to help companies prepare for IDMP and future regulations. ZS has created an IDMP-based enterprise product MDM data model, customized user interfaces, SPOR driven RDM with ready-to-use data mappings, and a document extraction tool that converts Summary of Product Characteristics (SmPC) and market authorizations into IDMP data. These solutions are easily configurable in client’s MDM ecosystem and enable them to manage product data based on IDMP standards.
ZS assets enabled enterprise product mastering in IDMP format offers several benefits. In the Regulatory & Development domain, it improves governance, enables efficient regulatory submissions, and reduces risk of revenue penalties. In Pharmaceutical manufacturing, it streamlines data, reduces order errors, and enables accurate inventory planning. In the Commercial domain, it allows for global product information mapping, optimized market positioning, and operational efficiency in sales and CRM.
In summary, IDMP is a crucial regulation necessitating a unique identification of medicinal products in the pharmaceutical industry. This drives the need for robust data management solutions to ensure compliance, efficiency, and patient safety. ZS’s assets are ready-to-use and easily configurable within the client’s data management ecosystem, effectively optimizing the enterprise MDM setup journey.
To learn more, please reach out to me, Himanshu Vashishta (himanshu.vashishta@zs.com) or Bronwen Schumacher (Bronwen.schumacher@zs.com). Please also refer to our website to learn more about ZS.
